Risperidone (depot) for schizophrenia

Stephanie Sampson; Prakash Hosalli; Vivek A Furtado; John M Davis

doi:10.1002/14651858.CD004161.pub2

Cochrane Database of Systematic Reviews

Risperidona (de depósito) para la esquizofrenia

Información

DOI:

https://doi.org/10.1002/14651858.CD004161.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

14 abril 2016see what's new

Tipo:

Intervention

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Esquizofrenia

Copyright:

Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Contraer

Autores

Stephanie Sampson

Correspondencia a: The University of Nottingham, Nottingham, UK

[email protected]
Prakash Hosalli

The Newsam Centre, Seacroft Hospital, Leeds, UK
Vivek A Furtado

Division of Mental Health and Wellbeing, Warwick Medical School, University of Warwick, Coventry, UK
John M Davis

University of Illinois at Chicago, Chicago, USA

Contributions of authors

Prakash Hosalli ‐ initiated the review, selected studies, extracted data, wrote the protocol and the review.

Steph Sampson ‐ checked data extraction, contributed towards review update development, economic evaluation of included studies.

Vivek Furtado ‐ economic evaluation of included studies.

John Davis ‐ helped write the protocol, independently selected and extracted data and helped write the review.

Sources of support

Internal sources

Leeds Community Mental Health NHS trust, UK.
University of Leeds, UK.
University of Illinois at Chicago, USA.

External sources

National Institute for Health Research (NIHR), UK.

Cochrane Collaboration Programme Grant 2011; Reference number: 10/4001/15

Declarations of interest

Prakash Hosalli ‐ none known.

Steph Sampson ‐ none known.

Vivek Furtado ‐ none known.

John Davis ‐ none known.

Acknowledgements

The Cochrane Schiozphrenia Group provide a template for the Methods section, we have used this template and adapted for our criteria.

We would like to thank Thomas Neely who contributed to writing, trial selection and data extraction for the 2015 version. We would also like to thank Nancy Covell for her assistance in obtaining further information to an included study, and Nicholas Keks for providing further information relating to statistical analysis in his study.

We would also like to thank Ben Gray for writing our Plain language summary, and copy editors for making the review read better and look consistent.

“This project was supported by the National Institute for Health Research, via Cochrane Infrastructure funding to the Schizophrenia Group. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Systematic Reviews Programme, NIHR, NHS or the Department of Health.”

Version history

Published

Title

Stage

Authors

Version

2016 Apr 14

Risperidone (depot) for schizophrenia

Review

Stephanie Sampson, Prakash Hosalli, Vivek A Furtado, John M Davis

https://doi.org/10.1002/14651858.CD004161.pub2

2003 Oct 20

Depot risperidone for schizophrenia

Review

Prakash Hosalli, John M Davis

https://doi.org/10.1002/14651858.CD004161

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans;

PICO

Population

Intervention

Comparison

Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Figure 1

Study flow diagram: 2010 and 2012, 2015 updated search

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Figure 2

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Figure 3

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Analysis 1.1

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 1 Mental state: 1. Change (exacerbation) in specific symptoms.

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Analysis 1.2

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 2 Leaving the study early: 1. Any reason (by time period).

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Analysis 1.3

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 3 Leaving the study early: 2. Any reason (by doses).

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Analysis 1.4

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 4 Leaving the study early: 3. Because of insufficient response (by doses).

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Analysis 1.5

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 5 Adverse events: 1. General: a. Death.

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Analysis 1.6

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 6 Adverse events: 1. General: b. Severe adverse event (by doses).

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Analysis 1.7

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 7 Adverse events: 1. General: c. Adverse event necessitating withdrawal from study (by doses).

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Analysis 1.8

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 8 Adverse events: 2. Specific: a. Cardiovascular.

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Analysis 1.9

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 9 Adverse events: 2. Specific: b. Gastrointestinal.

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Analysis 1.10

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 10 Adverse events: 2. Specific: c. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by doses).

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Analysis 1.11

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 11 Adverse events: 2. Specific: d. Movement disorders: b. Hyperkinesia (by doses).

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Analysis 1.12

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 12 Adverse events: 2. Specific: e. Movement disorders: c. Hypertonia (by doses).

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Analysis 1.13

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 13 Adverse events: 2. Specific: f. Pain.

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Analysis 1.14

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 14 Adverse events: 2. Specific: g. Salivation.

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Analysis 1.15

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 15 Adverse events: 2. Specific: h. Sleep disturbances.

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Analysis 1.16

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 16 Adverse events: 2. Specific: i. Weight gain.

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Analysis 1.17

Comparison 1 RISPERIDONE DEPOT vs PLACEBO, Outcome 17 Adverse events: 2. Specific: j. Others.

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Analysis 2.1

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 1 Global state: 1. Relapse (any reason).

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Analysis 2.2

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 2 Global state: 2. Needing use of benzodiazepine or sedative drugs.

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Analysis 2.3

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 3 Service utilisation: 1. Hospitalisation.

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Study	Intervention	Mean	SD	N
long term
Rosenheck 2011	Risperidone depot	122.4	130.9	187
Rosenheck 2011	Oral control	136.5	137	182

Analysis 2.4

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 4 Service utilisation: 2. Outpatient care ‐ number of outpatient visits (skewed data).

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Analysis 2.5

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 5 Not receiving allocated study medication.

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Analysis 2.6

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 6 Leaving the study early: 1. Any reason.

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Analysis 2.7

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 7 Leaving the study early: 2. Specific.

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Analysis 2.8

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 8 Adverse events: 1. General: a. Death.

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Analysis 2.9

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 9 Adverse events: 2. Specific.

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Analysis 2.10

Comparison 2 RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS, Outcome 10 Adverse events: Nervous system disorders (inc. EPS).

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Analysis 3.1

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 1 Global state: 1. Moderate to severely ill at end of study period (CGI rating).

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Analysis 3.2

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 2 Global state: 2. Mean change from baseline (CGI‐S, high score = worse).

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Analysis 3.3

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 3 Global state: 3. Mean (SD) GAF score change to endpoint.

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Analysis 3.4

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 4 Global state: 4. Needing use of benzodiazepine or sedative drugs.

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Analysis 3.5

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 5 Mental state: 1. Average change/endpoint scores (PANSS, high score = worse).

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Analysis 3.6

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 6 Leaving the study early: 1. Any reason.

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Analysis 3.7

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 7 Leaving the study early: 2. Specific.

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Analysis 3.8

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 8 Quality of life: Mean (SD) SF‐36 score change/endpoint (high score = better).

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Analysis 3.9

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 9 Adverse events: 1. General.

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Analysis 3.10

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 10 Adverse events: 1. General: UKU average change score (high = worse).

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Analysis 3.11

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 11 Adverse events: 2. Specific.

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Analysis 3.12

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 12 Adverse events: 2. Specific: Mean (SD) weight increase in kg.

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Analysis 3.13

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 13 Adverse events: 3. Movement disorder.

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Analysis 3.14

Comparison 3 RISPERIDONE DEPOT vs ORAL RISPERIDONE, Outcome 14 Adverse events: Mean (SD) change in movement disorder rating scales.

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Analysis 4.1

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 1 Leaving the study early: 1. Any reason.

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Analysis 4.2

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 2 Leaving the study early: 2. Specific.

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Analysis 4.3

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 3 Adverse events: 1. General.

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Analysis 4.4

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 4 Adverse events: 2. Specifc.

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Analysis 4.5

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 5 Adverse events: 2. Specific: Mean (SD) weight increase in kg.

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Analysis 4.6

Comparison 4 RISPERIDONE DEPOT vs ORAL QUETIAPINE, Outcome 6 Adverse events: 3. Movement disorder.

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Analysis 5.1

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 1 Global state: 1. Relapse (any reason).

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Analysis 5.2

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 2 Global state: 3. Mean time in remission (days).

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Analysis 5.3

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 3 Mental state: 1. Average change scores (PANSS, high score = worse).

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Analysis 5.4

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 4 Leaving the study early: 1. Any reason.

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Analysis 5.5

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 5 Leaving the study early: 2. Specific.

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Analysis 5.6

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 6 Adverse events: 1. General.

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Analysis 5.7

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 7 Adverse events: 2. Specific.

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Analysis 5.8

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 8 Adverse events: 2. Specific 12. Mean (SD) weight increase in kg.

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Analysis 5.9

Comparison 5 RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE, Outcome 9 Adverse events: 3. Movement disorder.

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Analysis 6.1

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 1 Mental state: 1. Average change scores (PANNS, high score = worse).

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Analysis 6.2

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 2 Leaving the study early: 1. Any reason.

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Analysis 6.3

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 3 Leaving the study early: 2. Specific.

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Analysis 6.4

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 4 Adverse events: 1. General.

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Analysis 6.5

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 5 Adverse events: 2. Specific.

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Analysis 6.6

Comparison 6 RISPERIDONE DEPOT vs ORAL OLANZAPINE, Outcome 6 Adverse events: 3. Movement disorder.

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Analysis 7.1

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 1 Global state: 1. Relapse (any reason).

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Analysis 7.2

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 2 Mental state: 1. Average change scores (PANSS, high score = worse) 1. total.

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Analysis 7.3

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 3 Leaving the study early: 1. Any reason.

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Analysis 7.4

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 4 Adverse events: 1. Death.

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Analysis 7.5

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 5 Adverse events: 1. General: a. any.

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Analysis 7.6

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 6 Adverse events: 1. General: b. serious.

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Analysis 7.7

Comparison 7 RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES), Outcome 7 Adverse events: 2. Movement disorder: a. any extra pyramidal symptoms.

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Analysis 8.1

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 1 Global State: 1. CGI‐S mean change from baseline (high score = worse).

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Analysis 8.2

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 2 Global state: 2. Schedule for Deficit Syndrome (SDS) scale (mean change from baseline, high score = worse).

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Analysis 8.3

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 3 Mental state: 1. PANSS scores (high score = worse) ‐ medium term.

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Analysis 8.4

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 4 Mental state: 2. Improved by 30% in total PANSS score (ITT data).

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Analysis 8.5

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 5 General functioning: Personal and Social Performance (PSP) scale (high score = better).

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Analysis 8.6

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 6 Leaving the study early: 1. Any reason.

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Analysis 8.7

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 7 Adverse events: 1. General.

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Analysis 8.8

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 8 Adverse events: 2. Specific.

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Analysis 8.9

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 9 Adverse events: 3. Prolactin related.

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Analysis 8.10

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 10 Adverse events: 4. Movement disorder.

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Analysis 8.11

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 11 Adverse events: 5. Body weight (mean increase).

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Analysis 8.12

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 12 Adverse events: 6. Mean prolactin level increase (ng/mL).

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Analysis 8.13

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 13 Adverse events: 7. Glucose related.

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Analysis 8.14

Comparison 8 RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE), Outcome 14 Adverse events: 8. Injection site pain (mean (sd) Visual Analogue Scale score (0‐100mm)).

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Analysis 9.1

Comparison 9 RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS, Outcome 1 Mental state: 1. Total endpoint scores (PANNS, high score = worse).

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Analysis 9.2

Comparison 9 RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS, Outcome 2 Leaving the study early.

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Analysis 9.3

Comparison 9 RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS, Outcome 3 Hospitalisation by 6 months.

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Study	Intervention	Mean	SD	N
Change in BMI ‐ short term (skew)
Covell 2012	Risperidone depot	1.29	1.9	23
Covell 2012	Typical depot antipsychotics	0.48	1.4	26
Change in BMI ‐ medium term (skew)
Covell 2012	Risperidone depot	1.53	2.2	22
Covell 2012	Typical depot antipsychotics	0.53	1.3	24
Change in BMI ‐ long term (skew)
Covell 2012	Risperidone depot	1.04	2.0	17
Covell 2012	Typical depot antipsychotics	‐0.28	1.7	24
Prolactin endpoint levels (ng/mL) ‐ short term (skew)
Covell 2012	Risperidone depot	22.5	19.1	19
Covell 2012	Typical depot antipsychotics	15.1	7.6	22
Prolactin endpoint levels (ng/mL) ‐ medium term (skew)
Covell 2012	Risperidone depot	23.4	13.8	18
Covell 2012	Typical depot antipsychotics	16	7.5	21
Prolactin endpoint levels (ng/mL) ‐ long term (skew)
Covell 2012	Risperidone depot	19	10.6	14
Covell 2012	Typical depot antipsychotics	15.2	5.1	18

Analysis 9.4

Comparison 9 RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS, Outcome 4 Adverse events: 1. Continuous outcomes (skew).

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Analysis 9.5

Comparison 9 RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS, Outcome 5 Adverse events: 2. Sexual experiencesm, total endpoint (ASEX, high score = worse).

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Table 1. Suggested design of study

Methods	Allocation: randomised, fully explicit description of methods of randomisation and allocation concealment. Blinding: single, tested. Setting: community rather than hospital. Duration: 12 weeks treatment, and then follow‐up to at least 52 weeks.
Participants	Diagnosis: schizophrenia (ICD/DSM/CCMD). N = 300.* Age: adults. Sex: both.
Interventions	1. Depot risperidone. N = 150. 2. Standard care. N = 150.
Outcomes	General: time to all‐cause treatment failure marked by its discontinuation, relapse, general impression of clinician (CGI), career/other, compliance with treatment., healthy days, Mental state: BPRS and PANSS. Global state: CGI (Clinical Global Impression). Quality of life. QOL (Quality of Life Questionnaire). Family burden: FBQ (Family Burden Questionnaire). Social functioning: return to everyday living for 80% of time.* Adverse events: any adverse event recorded. Economic outcomes.
Notes	* Powered to be able to identify a difference of ˜ 20% between groups for primary outcome with adequate degree of certainty.
BPRS: Brief Psychiatric Rating Scale CGI: Clinical Global Impression PANSS: Positive and Negative Syndrome Scale

Table 1. Suggested design of study

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Table 2. Excluded studies and suggestions for relevant reviews

Excluded study	Comparison	Existing review	Suggested future review titles
Bouchard 2000; Gallhofer 1995; Kogeorgos 1995;	Oral risperidone vs conventional antipsychotic drugs (haloperidol, fluphenazine, chlorpromazine, trifluoperazine), not depot risperidone.	Risperidone vs typical antipsychotic medication for schizophrenia (Hunter 2003).	Risperidone vs haloperidol, risperidone vs fluphenazine, risperidone vs chlorpromazine, risperidone vs trifluoperazine.
Littrell 1999; Ritchie 1999; Robinson 2000	Oral risperidone vs atypical antipsychotics (olanzapine), not depot risperidone.	Risperidone vs olanzapine for schizophrenia (Jayaram 2006).
Macfadden 2008; Simpson 2006	Dose comparison (25 mg vs 50 mg of risperidone depot).	Risperidone dose for schizophrenia (Li 2009).	This could also generate further comparisons for this current review.

Table 2. Excluded studies and suggestions for relevant reviews

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Summary of findings for the main comparison. RISPERIDONE DEPOT compared with PLACEBO for schizophrenia

RISPERIDONE DEPOT compared with PLACEBO for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: PLACEBO
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	PLACEBO	RISPERIDONE DEPOT
Global state: Relapse ‐ long term ‐ not measured	See comment	See comment	Not estimable	‐	See comment	No study reported this outcome.
Mental state: clinically significant improvement in mental state ‐ long term¹ ‐ not reported	See comment	See comment	Not estimable¹	‐	See comment	Study reported PANSS responder rate, but unusable due to high attrition.
Leaving the study early: Any reason ‐ all doses risperidone depot ‐ short term	694 per 1000	513 per 1000 (437 to 611)	RR 0.74 (0.63 to 0.88)	400 (1 study)	⊕⊝⊝⊝ very low^2,3
Adverse events: General: Severe adverse event ‐ any dose risperidone depot ‐ short term Spontaneous reporting by study participants	235 per 1000⁴	138 per 1000 (89 to 218)	RR 0.59 (0.38 to 0.93)	400 (1 study)	⊕⊝⊝⊝ very low^2,5
Adverse events: Specific: Weight gain ‐ all doses of depot risperidone ‐ short term Spontaneous reporting by study participants	20 per 1000	43 per 1000 (10 to 187)	RR 2.11 (0.48 to 9.18)	400 (1 study)	⊕⊝⊝⊝ very low^2,6
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Not reported: only included study (Kane 2002) reported PANSS responder rate, but these data were unusable due to high levels of attrition. ² Risk of bias: 'very serious' ‐ high attrition in one included study (Kane 2002) of greater than 50% overall. Research supported by Johnson and Johnson/ Janssen, producers of depot risperidone. ³ Imprecision: 'serious' ‐ only one small study reported data for this comparison. ⁴ Control risk: mean baseline presented for one individual study. ⁵ Imprecision: 'serious' ‐ adverse events were reported spontaneously by participants, rather than systematically assessed by the researchers. This could effect the precision of the results as there is only one study (Kane 2002) addressing this comparison. ⁶ Imprecision: 'serious'‐ the method of measuring weight gain and threshold for reporting it were not described. This could effect the precision of the results as there is only one study (Kane 2002) addressing this comparison.

Summary of findings for the main comparison. RISPERIDONE DEPOT compared with PLACEBO for schizophrenia

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Summary of findings 2. RISPERIDONE DEPOT compared with GENERAL ORAL ANTIPSYCHOTICS for schizophrenia

RISPERIDONE DEPOT compared with GENERAL ORAL ANTIPSYCHOTICS for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: GENERAL ORAL ANTIPSYCHOTICS
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	GENERAL ORAL ANTIPSYCHOTICS	RISPERIDONE DEPOT
Global state: Relapse (any reason) ‐ long term Number of participants relapsing in each treatment arm.	Moderate		RR 2.13 (0.84 to 5.43)	63 (1 study)	⊕⊝⊝⊝ very low^2,3	Criteria for relapse were derived from Csernansky 2002.<BR/>
	161 per 1000¹	343 per 1000 (135 to 874)
Mental state: clinically significant improvement in mental state ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to mental state were unusable due to high study attrition.
Leaving the study early: Any reason ‐ long term	Study population		RR 1.24 (0.98 to 1.57)	467 (2 studies)	⊕⊕⊕⊝ moderate
	322 per 1000⁴	399 per 1000 (315 to 505)
	Moderate
	387 per 1000⁴	480 per 1000 (379 to 608)
Adverse events: General: Severe adverse event ‐ any dose risperidone depot ‐ short term	See comment	See comment	Not estimable	0 (0)	See comment	"Severe adverse events" were not explicitly reported.
Adverse events: Specific ‐ prolactin‐related ‐ long term It is unclear how adverse events were reported	Low		RR 10.27 (0.59 to 180.05)	85 (1 study)	⊕⊝⊝⊝ very low^2,6
	10 per 1000⁵	103 per 1000 (6 to 1000)
	Moderate
	100 per 1000⁵	1000 per 1000 (59 to 1000)
	High
	200 per 1000⁵	1000 per 1000 (118 to 1000)
Adverse events: Specific ‐ weight increase ‐ long term It is unclear how adverse events were reported	Study population		RR 1.33 (0.56 to 3.17)	85 (1 study)	⊕⊝⊝⊝ very low^2,6
	171 per 1000⁴	227 per 1000 (96 to 541)
	Moderate
	171 per 1000⁴	227 per 1000 (96 to 542)
Adverse events: Nervous system disorders (inc. EPS) ‐ long term It is unclear how adverse events were reported	Study population		RR 1.34 (1.13 to 1.58)	369 (1 study)	⊕⊝⊝⊝ very low^2,6
	171 per 1000⁴	227 per 1000 (96 to 541)
	Moderate
	171 per 1000⁴	227 per 1000 (96 to 542)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Assumed risk: mean baseline presented for one individual study. ² Risk of bias: 'very serious' ‐ a high level of attrition (> 50%), the open‐label nature of this study and the fact that it was supported by the manufacturers of depot risperidone result in a very serious risk of bias. ³ Imprecision: 'serious' ‐ the sample size for this outcome was small (n = 63). ⁴ Assumed risk: median control group risk from the studies. ⁵ Assumed risk: control risk relates to 'low' (0%). ⁶ Serious risk of imprecision due to the small sample size of this study.

Summary of findings 2. RISPERIDONE DEPOT compared with GENERAL ORAL ANTIPSYCHOTICS for schizophrenia

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Summary of findings 3. RISPERIDONE DEPOT compared with ORAL RISPERIDONE for schizophrenia

RISPERIDONE DEPOT compared with ORAL RISPERIDONE for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL RISPERIDONE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORAL RISPERIDONE	RISPERIDONE DEPOT
Global state: Relapse ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to relapse were not available for this comparison.
Mental state: average PANSS total score at endpoint (non‐ITT data) PANSS total scores (30 to 210) Higher scores are worse.		The mean mental state: average PANSS total score at endpoint (non‐ITT data) in the intervention groups was 1.05 higher (0.77 lower to 2.88 higher)		591 (2 studies)	⊕⊕⊕⊝ moderate¹
Leaving the study early: Any reason ‐ short term	Study population		RR 1.28 (0.92 to 1.79)	690 (2 studies)	⊕⊕⊕⊝ moderate¹
	145 per 1000²	185 per 1000 (133 to 259)
	Moderate
	78 per 1000²	100 per 1000 (72 to 140)
Adverse events: General: Severe adverse event ‐ any dose risperidone depot ‐ short term	See comment	See comment	Not estimable	0 (0)	See comment	"Severe adverse events" were not explicitly reported by these studies.
Adverse events: Movement disorder ‐ any extra pyramidal symptoms ‐ short term	Study population		RR 1.05 (0.59 to 1.88)	640 (1 study)	⊕⊕⊕⊝ moderate⁴
	65 per 1000³	69 per 1000 (39 to 123)
	Moderate
	65 per 1000³	68 per 1000 (38 to 122)
Adverse events: Specific: Mean (SD) weight increase in kg ‐ short term	The mean adverse events: specific: mean (SD) weight increase in kg ‐ short term in the control groups was 0.2 points	The mean adverse events: specific: mean (SD) weight increase in kg ‐ short term in the intervention groups was 0.2 higher (0.35 lower to 0.75 higher)		640 (1 study)	⊕⊕⊕⊝ moderate⁴
Adverse events: Specific ‐ prolactin‐related	Moderate		RR 0.5 (0.15 to 1.65)	640 (1 study)	⊕⊕⊕⊝ moderate⁴
	25 per 1000³	12 per 1000 (4 to 41)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Risk of bias: 'serious' ‐ both studies received funding support from the manufacturers of risperidone depot ² Assumed risk: median control group risk from the studies. ³ Assumed risk: mean baseline presented for one individual study. ⁴ Risk of bias: 'serious' ‐ this research was supported by the manufacturers of risperidone depot.

Summary of findings 3. RISPERIDONE DEPOT compared with ORAL RISPERIDONE for schizophrenia

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Summary of findings 4. RISPERIDONE DEPOT compared with ORAL QUETIAPINE for schizophrenia

RISPERIDONE DEPOT compared with ORAL QUETIAPINE for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL QUETIAPINE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORAL QUETIAPINE	RISPERIDONE DEPOT
Global state: Relapse ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Criteria for relapse were derived from Csernansky 2002. <BR/> Outcomes relating to relapse were reported, but were unusable due to study attrition.
Mental state: clinically significant improvement in mental state ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to mental state were unusable due to high study attrition.
Leaving the study early: Any reason ‐ long term	Moderate		RR 0.84 (0.74 to 0.95)	666 (1 study)	⊕⊕⊕⊝ moderate^2,3
	644 per 1000¹	541 per 1000 (477 to 612)
Adverse events: General ‐ serious Recorded at each follow‐up visit.	Moderate		RR 0.84 (0.62 to 1.13)	666 (1 study)	⊕⊕⊝⊝ low^2,3,4
	229 per 1000¹	192 per 1000 (142 to 259)
Adverse events: Movement disorder ‐ any extra pyramidal symptom	Moderate		RR 1.83 (1.07 to 3.15)	666 (1 study)	⊕⊕⊝⊝ low^2,3,4
	56 per 1000¹	102 per 1000 (60 to 176)
Adverse events: Specific: Mean (SD) weight increase in kg ‐ long term		The mean adverse events: specific: mean (SD) weight increase in kg ‐ long term in the intervention groups was 1.25 higher (0.25 to 2.25 higher)		666 (1 study)	⊕⊕⊝⊝ low^2,3,4
Adverse events: Specific ‐ prolactin‐related Reported by participants at follow‐up visits	Study population		RR 3.07 (1.13 to 8.36)	666 (1 study)	⊕⊕⊝⊝ low^2,3,4
	15 per 1000¹	46 per 1000 (17 to 124)
	Moderate
	15 per 1000¹	46 per 1000 (17 to 125)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Assumed risk: mean baseline risk used for one included study. ² Risk of bias: 'serious' ‐ this study was supported by the manufacturers of risperidone depot. ³ Risk of bias: 'serious' ‐ this study was open‐label in nature. ⁴ Risk of bias: 'very serious' ‐ study attrition was high (> 50%).

Summary of findings 4. RISPERIDONE DEPOT compared with ORAL QUETIAPINE for schizophrenia

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Summary of findings 5. RISPERIDONE DEPOT compared with ORAL ARIPIPRAZOLE for schizophrenia

RISPERIDONE DEPOT compared with ORAL ARIPIPRAZOLE for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL ARIPIPRAZOLE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORAL ARIPIPRAZOLE	RISPERIDONE DEPOT
Global state: Relapse (any reason) ‐ long term Assessed by 5 blinded raters in accordance with study criteria (see comment).	Moderate		RR 1.05 (0.83 to 1.33)	349 (1 study)	⊕⊕⊝⊝ low^2,3	Criteria for relapse were derived from Csernansky 2002.
	436 per 1000¹	458 per 1000 (362 to 580)
Mental state: Average change scores‐ long term PANSS total score (30 to 210), higher scores are worse.		The mean mental state: average change scores‐ long term in the intervention groups was 0.1 lower (3.15 lower to 2.95 higher)		349 (1 study)	⊕⊕⊝⊝ low^2,3
Leaving the study early: Any reason ‐ long term	Study population		RR 0.83 (0.53 to 1.3)	723 (2 studies)	⊕⊝⊝⊝ very low^5,6
	387 per 1000⁴	321 per 1000 (205 to 503)
	Moderate
	531 per 1000⁴	441 per 1000 (281 to 690)
Adverse events: General ‐ serious Unclear how these events were reported	Study population		RR 0.96 (0.66 to 1.39)	729 (2 studies)	⊕⊝⊝⊝ very low^5,6
	190 per 1000⁴	182 per 1000 (125 to 264)
	Moderate
	177 per 1000⁴	170 per 1000 (117 to 246)
Adverse events: Movement disorder ‐ any extra pyramidal symptoms	Study population		RR 1.19 (0.91 to 1.55)	729 (2 studies)	⊕⊝⊝⊝ very low^5,6
	285 per 1000⁴	339 per 1000 (259 to 442)
	Moderate
	196 per 1000⁴	233 per 1000 (178 to 304)
Adverse events: Specific ‐ weight increase	Moderate		RR 1.57 (0.38 to 6.45)	374 (1 study)	⊕⊕⊝⊝ low^2,3
	44 per 1000¹	69 per 1000 (17 to 284)
Adverse events: Specific ‐ prolactin‐related	Study population		RR 9.91 (2.78 to 35.29)	729 (2 studies)	⊕⊝⊝⊝ very low^5,6
	9 per 1000⁴	90 per 1000 (25 to 319)
	Moderate
	6 per 1000⁴	59 per 1000 (17 to 212)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Assumed risk: mean baseline risk presented for one individual study. ² Risk of bias: 'very serious' ‐ a number of the study authors were employed by the manufacturers of risperidone depot at the time of the study. ³ Risk of bias: 'serious' ‐ serious risk of bias due to the open nature label of the study. ⁴ Assumed risk: median control group risk from the studies. ⁵ Risk of bias: 'very serious' ‐ serious risk of bias as both studies were open‐label and supported by the manufacturers of risperidone depot. ⁶ Imprecision: 'serious' ‐ possibly serious risk of imprecision in Gaebel 2010* as the aripiprazole arm of this study was very small (n = 45) compared to the risperidone depot (n = 329) arm.

Summary of findings 5. RISPERIDONE DEPOT compared with ORAL ARIPIPRAZOLE for schizophrenia

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Summary of findings 6. RISPERIDONE DEPOT compared with ORAL OLANZAPINE for schizophrenia

RISPERIDONE DEPOT compared with ORAL OLANZAPINE for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ORAL OLANZAPINE
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ORAL OLANZAPINE	RISPERIDONE DEPOT
Global state: Relapse ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to relapse were not reported for this comparison.
Mental state: Average change scores ‐ long term PANSS total score (30‐210), high scores are worse.		The mean mental state: average change scores ‐ long term in the intervention groups was 0.1 higher (3.96 lower to 4.16 higher)		361 (1 study)	⊕⊕⊝⊝ low^1,2,3
Leaving the study early: Any reason ‐ long term	Study population		RR 1.32 (1.1 to 1.58)	618 (1 study)	⊕⊕⊝⊝ low^1,2,3
	377 per 1000⁴	497 per 1000 (414 to 595)
	Moderate
	377 per 1000⁴	498 per 1000 (415 to 596)
Adverse events: General ‐ serious	Moderate		RR 1.1 (0.8 to 1.51)	547 (1 study)	⊕⊕⊝⊝ low^1,2,3
	210 per 1000⁴	231 per 1000 (168 to 317)
Adverse events: Movement disorder ‐ any extra pyramidal symptoms	Moderate		RR 1.67 (1.19 to 2.36)	547 (1 study)	⊕⊕⊝⊝ low^1,2,3
	150 per 1000⁴	250 per 1000 (179 to 354)
Adverse events: Specific ‐ weight increase	Moderate		RR 0.56 (0.42 to 0.75)	547 (1 study)	⊕⊕⊝⊝ low^1,2,3
	360 per 1000⁴	202 per 1000 (151 to 270)
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Risk of bias: 'very serious' ‐ serious risk of bias due to study attrition in excess of 50%. ² Risk of bias: 'serious' ‐ serious risk of bias as this study was supported by the manufacturers of risperidone depot, and some of the authors are employed by the same. ³ Risk of bias: 'serious' ‐ serious risk of bias due to the open‐label nature of the study. ⁴ Assumed risk: mean baseline risk from one included study.

Summary of findings 6. RISPERIDONE DEPOT compared with ORAL OLANZAPINE for schizophrenia

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Summary of findings 7. RISPERIDONE DEPOT compared with ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE) for schizophrenia

RISPERIDONE DEPOT compared with ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE) for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE)	RISPERIDONE DEPOT
Global state: Relapse ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to relapse were not reported for this comparison.
Mental state: PANSS responders (ITT data) ‐ medium term PANSS responders‐ participants achieving a >30% improvement in total score	Study population		RR 1.01 (0.83 to 1.23)	1326 (2 studies)	⊕⊕⊕⊝ moderate^2,3
	585 per 1000¹	591 per 1000 (486 to 720)
	Moderate
	619 per 1000¹	625 per 1000 (514 to 761)
Leaving the study early: lack of efficacy ‐ long term	Study population		RR 0.60 (0.45 to 0.81)	749 (1 study)	⊕⊕⊝⊝ low^2,3,4
	361 per 1000¹	307 per 1000 (275 to 340)
	Moderate
	280 per 1000¹	238 per 1000 (213 to 263)
Adverse events: Movement disorder requiring the use of anti‐EPS medication ‐ medium term	Study population		RR 1.46 (1.18 to 1.8)	1666 (2 studies)	⊕⊕⊕⊝ moderate^2,3,5
	122 per 1000¹	178 per 1000 (144 to 220)
	Moderate
	182 per 1000¹	266 per 1000 (215 to 328)
Adverse events: Body weight (mean increase) ‐ medium/long term		The mean adverse events: body weight (mean increase) ‐ medium/long term in the intervention groups was 0.18 higher (0.36 lower to 0.72 higher)		2350 (3 studies)	⊕⊕⊝⊝ low^2,3,4
Adverse events: Any prolactin‐related ‐ medium term	Study population		RR 1.02 (0.61 to 1.71)	1666 (2 studies)	⊕⊕⊕⊝ moderate^2,3
	32 per 1000¹	33 per 1000 (20 to 55)
	Moderate
	48 per 1000¹	49 per 1000 (29 to 82)
Adverse events: Any glucose‐related ‐ medium/long term	10 per 1000¹	18 per 1000 (9 to 36)	RR 1.79 (0.89 to 3.61)	2413 (3 studies)	⊕⊕⊝⊝ low^2,3,4
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Assumed risk: median control group risk from the studies. ² Risk of bias: 'serious' ‐ Li 2011 was open‐label and supported by the manufacturer of risperidone depot. ³ Risk of bias: 'serious' ‐ Pandina 2011 was supported by the manufacturer of risperidone depot. ⁴ Risk of bias: 'serious' ‐ as the attrition rate of Fleischhacker 2011 was in excess of 50%, and the study was supported by the manufacturer of risperidone depot. ⁵ Possible imprecision: the rate of movement disorder requiring anti‐EPS medication may not be a reflection of the true rate of movement disorders.

Summary of findings 7. RISPERIDONE DEPOT compared with ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE) for schizophrenia

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Summary of findings 8. RISPERIDONE DEPOT compared with TYPICAL DEPOT ANTIPSYCHOTICS for schizophrenia

RISPERIDONE DEPOT compared with TYPICAL DEPOT ANTIPSYCHOTICS for schizophrenia
Patient or population: patients with schizophrenia Settings: Intervention: RISPERIDONE DEPOT Comparison: TYPICAL DEPOT ANTIPSYCHOTICS
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	TYPICAL DEPOT ANTIPSYCHOTICS	RISPERIDONE DEPOT
Global state: Relapse ‐ long term	See comment	See comment	Not estimable	0 (0)	See comment	Outcomes relating to relapse were not reported for this comparison.
Mental state: Total average scores (PANSS, high score = worse) ‐ long term		The mean mental state: total average scores (PANSS, high score = worse) ‐ long term in the intervention groups was 1.8 higher (10.04 lower to 13.64 higher)		43 (1 study)	⊕⊕⊝⊝ low^1,2
Leaving the study early for any reason ‐ long term	Study population		RR 3.05 (1.12 to 8.31)	62 (1 study)	⊕⊕⊝⊝ low^1,2
	133 per 1000³	407 per 1000 (149 to 1000)
	Moderate
	133 per 1000³	406 per 1000 (149 to 1000)
Adverse events: General: Severe adverse event	See comment	See comment	Not estimable	0 (0)	See comment	"Severe adverse events" were not explicitly reported for this comparison.
Adverse events: related to movement disorder, weight gain, prolactin levels and glucose metabolism ‐ medium/long term ‐ not reported	See comment	See comment	Not estimable	‐	See comment	Outcomes relating to specific adverse events were not reported in such as way as to be useable.
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio;
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate.
¹ Risk of bias: 'serious' ‐ due to the open‐label nature of this study. ² Imprecision: 'serious' ‐ due to the small size of the single study. ³ Assumed risk: median control group risk from the studies.

Summary of findings 8. RISPERIDONE DEPOT compared with TYPICAL DEPOT ANTIPSYCHOTICS for schizophrenia

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Comparison 1. RISPERIDONE DEPOT vs PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: 1. Change (exacerbation) in specific symptoms Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 anxiety ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.32, 1.05]
1.2 agitation ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.39, 0.92]
1.3 hallucinations ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.47, 3.22]
1.4 nervousness ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.39 [0.12, 1.25]
1.5 psychosis ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.52 [0.33, 0.83]
2 Leaving the study early: 1. Any reason (by time period) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 very early on (<1 injection)	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.55, 3.08]
2.2 by 12 weeks	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.63, 0.88]
3 Leaving the study early: 2. Any reason (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 all doses risperidone depot ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.63, 0.88]
3.2 25mg risperidone depot ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.59, 0.94]
3.3 50mg risperidone depot ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.59, 0.93]
3.4 75mg risperidone depot ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.60, 0.94]
4 Leaving the study early: 3. Because of insufficient response (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 all three doses ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.36, 0.79]
4.2 25mg depot risperidone group ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.73 [0.45, 1.17]
4.3 50mg depot risperidone group ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.27, 0.83]
4.4 75mg depot risperidone group ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.39 [0.21, 0.72]
5 Adverse events: 1. General: a. Death Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.00, 2.65]
6 Adverse events: 1. General: b. Severe adverse event (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 any dose risperidone depot ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.38, 0.93]
6.2 25mg risperidone depot ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.30, 1.04]
6.3 50mg risperidone depot ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	0.58 [0.32, 1.06]
6.4 75mg risperidone depot ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.36, 1.15]
7 Adverse events: 1. General: c. Adverse event necessitating withdrawal from study (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 any dose risperidone depot ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.54, 1.84]
7.2 25mg risperidone depot ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.42, 1.96]
7.3 50mg risperidone depot ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.45, 2.02]
7.4 75mg risperidone depot ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.56, 2.35]
8 Adverse events: 2. Specific: a. Cardiovascular Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 dizziness ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.46 [0.62, 3.43]
8.2 tachycardia ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.32 [0.11, 0.98]
9 Adverse events: 2. Specific: b. Gastrointestinal Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 constipation ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	6.17 [0.84, 45.46]
9.2 diarrhoea ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.23, 3.20]
9.3 nausea ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.39, 2.76]
9.4 vomiting ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.59 [0.23, 1.57]
10 Adverse events: 2. Specific: c. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 all doses of depot risperidone ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	2.38 [0.73, 7.78]
10.2 25mg risperidone group ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	1.32 [0.30, 5.74]
10.3 50mg risperidone group ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	2.54 [0.69, 9.29]
10.4 75mg risperidone group ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	3.27 [0.93, 11.51]
11 Adverse events: 2. Specific: d. Movement disorders: b. Hyperkinesia (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

11.1 all doses of risperidone ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.70 [0.60, 4.84]
11.2 25mg risperidone group ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.09, 2.64]
11.3 50mg risperidone group ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	2.14 [0.68, 6.73]
11.4 75mg of risperidone group ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	2.45 [0.79, 7.55]
12 Adverse events: 2. Specific: e. Movement disorders: c. Hypertonia (by doses) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

12.1 all doses of depot risperidone ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.23 [0.47, 3.22]
12.2 25mg risperidone ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	0.79 [0.22, 2.86]
12.3 50mg risperidone ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	0.95 [0.28, 3.19]
12.4 75mg risperidone ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	1.96 [0.70, 5.53]
13 Adverse events: 2. Specific: f. Pain Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 headache ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.88, 2.80]
13.2 pain ‐ unspecified ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.38 [0.48, 4.00]
14 Adverse events: 2. Specific: g. Salivation Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

14.1 decreased ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	2.92 [0.37, 22.76]
14.2 increased ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	2.92 [0.37, 22.76]
15 Adverse events: 2. Specific: h. Sleep disturbances Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

15.1 insomnia ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.60, 1.82]
15.2 somnolence ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	2.27 [0.69, 7.45]
16 Adverse events: 2. Specific: i. Weight gain Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

16.1 all doses of depot risperidone ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	2.11 [0.48, 9.18]
16.2 25mg risperidone ‐ short term	1	197	Risk Ratio (M‐H, Random, 95% CI)	2.47 [0.49, 12.45]
16.3 50mg risperidone ‐ short term	1	201	Risk Ratio (M‐H, Random, 95% CI)	1.90 [0.36, 10.16]
16.4 75mg risperidone ‐ short term	1	198	Risk Ratio (M‐H, Random, 95% CI)	1.96 [0.37, 10.46]
17 Adverse events: 2. Specific: j. Others Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

17.1 coughing ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.97 [0.32, 2.95]
17.2 fatigue ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	8.82 [0.53, 147.05]
17.3 injury ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.13, 1.10]
17.4 rhinitis ‐ short term	1	400	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.47, 2.17]

Comparison 1. RISPERIDONE DEPOT vs PLACEBO

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Comparison 2. RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Relapse (any reason) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 long term	1	63	Risk Ratio (M‐H, Random, 95% CI)	2.13 [0.84, 5.43]
2 Global state: 2. Needing use of benzodiazepine or sedative drugs Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.68, 1.47]
3 Service utilisation: 1. Hospitalisation Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.68, 1.10]
4 Service utilisation: 2. Outpatient care ‐ number of outpatient visits (skewed data) Show forest plot			Other data	No numeric data

4.1 long term			Other data	No numeric data
5 Not receiving allocated study medication Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 long term	1	382	Risk Ratio (M‐H, Random, 95% CI)	0.29 [0.06, 1.37]
6 Leaving the study early: 1. Any reason Show forest plot	2	467	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.98, 1.57]

6.1 long term	2	467	Risk Ratio (M‐H, Random, 95% CI)	1.24 [0.98, 1.57]
7 Leaving the study early: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 insufficient response ‐ long term	1	382	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.15, 2.50]
7.2 withdrawn consent ‐ long term	1	382	Risk Ratio (M‐H, Random, 95% CI)	1.41 [0.86, 2.31]
8 Adverse events: 1. General: a. Death Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 long term	1	382	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.14, 7.10]
9 Adverse events: 2. Specific Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 anxiety ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.42, 4.60]
9.2 diabetes mellitus ‐ long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	1.70 [0.73, 3.96]
9.3 dizziness ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	1.49 [0.53, 4.19]
9.4 fatigue/somnolence ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	2.05 [0.78, 5.40]
9.5 gastrointestinal ‐ long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.95, 1.28]
9.6 general disorders and administration site conditions ‐ long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	1.31 [1.02, 1.69]
9.7 headache ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	2.80 [1.12, 7.00]
9.8 insomnia ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	1.73 [0.77, 3.91]
9.9 nausea/ vomiting ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	1.86 [0.50, 6.97]
9.10 prolactin related ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	10.27 [0.59, 180.05]
9.11 weight increase ‐ long term	1	85	Risk Ratio (M‐H, Random, 95% CI)	1.33 [0.56, 3.17]
10 Adverse events: Nervous system disorders (inc. EPS) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 long term	1	369	Risk Ratio (M‐H, Random, 95% CI)	1.34 [1.13, 1.58]

Comparison 2. RISPERIDONE DEPOT vs GENERAL ORAL ANTIPSYCHOTICS

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Comparison 3. RISPERIDONE DEPOT vs ORAL RISPERIDONE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Moderate to severely ill at end of study period (CGI rating) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.06 [0.92, 1.22]
2 Global state: 2. Mean change from baseline (CGI‐S, high score = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 short term	1	50	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.25, 0.17]
3 Global state: 3. Mean (SD) GAF score change to endpoint Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 short term	1	50	Mean Difference (IV, Random, 95% CI)	‐0.8 [‐5.66, 4.06]
4 Global state: 4. Needing use of benzodiazepine or sedative drugs Show forest plot	2	690	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.74, 1.02]

4.1 short term	2	690	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.74, 1.02]
5 Mental state: 1. Average change/endpoint scores (PANSS, high score = worse) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 mean total (non ITT data)	1	541	Mean Difference (IV, Random, 95% CI)	0.0 [‐2.91, 2.91]
5.2 average change: 1. total (non ITT data)	2	591	Mean Difference (IV, Random, 95% CI)	1.05 [‐0.77, 2.88]
5.3 average change: 2. positive (non‐ITT data)	2	591	Mean Difference (IV, Random, 95% CI)	0.83 [‐0.69, 2.35]
5.4 average change: 3. negative (non ITT data)	2	591	Mean Difference (IV, Random, 95% CI)	0.03 [‐0.76, 0.82]
5.5 average change: 4. disorganised thoughts	1	541	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.45, 0.65]
5.6 average change: 5. hostility/excitement	1	541	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.18, 0.38]
5.7 average change: 6. anxiety/depression	1	541	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.45, 0.65]
6 Leaving the study early: 1. Any reason Show forest plot	2	690	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.92, 1.79]

6.1 short term	2	690	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.92, 1.79]
7 Leaving the study early: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 adverse events ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.62, 2.35]
7.2 insufficient response ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.63, 3.64]
7.3 withdrawn consent ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.32 [0.65, 2.66]
8 Quality of life: Mean (SD) SF‐36 score change/endpoint (high score = better) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

8.1 Physical component summary	1	50	Mean Difference (IV, Random, 95% CI)	1.4 [‐2.64, 5.44]
8.2 Mental component summary	1	50	Mean Difference (IV, Random, 95% CI)	‐0.20 [‐5.06, 4.66]
8.3 Role physical	1	50	Mean Difference (IV, Random, 95% CI)	1.0 [‐20.71, 22.71]
8.4 Role emotional	1	50	Mean Difference (IV, Random, 95% CI)	‐10.60 [‐34.13, 12.93]
8.5 Vitality	1	50	Mean Difference (IV, Random, 95% CI)	‐1.6 [‐10.24, 7.04]
8.6 General health	1	50	Mean Difference (IV, Random, 95% CI)	‐2.60 [‐13.14, 7.94]
8.7 Mental health	1	50	Mean Difference (IV, Random, 95% CI)	5.8 [‐5.20, 16.80]
8.8 Bodily pain	1	50	Mean Difference (IV, Random, 95% CI)	3.70 [‐9.89, 17.29]
8.9 Physical function	1	50	Mean Difference (IV, Random, 95% CI)	‐4.6 [‐14.25, 5.05]
8.10 Social function	1	50	Mean Difference (IV, Random, 95% CI)	18.5 [3.98, 33.02]
9 Adverse events: 1. General Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 any ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.91, 1.18]
9.2 death ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.20]
10 Adverse events: 1. General: UKU average change score (high = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

10.1 short term	1	50	Mean Difference (IV, Random, 95% CI)	‐1.99 [‐3.59, ‐0.39]
11 Adverse events: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

11.1 anxiety	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.40 [0.84, 2.34]
11.2 psychosis	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.58, 2.24]
11.3 prolactin related	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.15, 1.65]
11.4 impotence/ejaculation failure	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.20]
11.5 dysmenorrhoea	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.06, 16.02]
11.6 hyperprolactinaemia	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.01, 4.18]
11.7 galactorrhoea	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.14, 7.10]
11.8 headache	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.14 [0.66, 1.95]
11.9 insomnia	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.08 [0.66, 1.74]
11.10 sexual dysfunction	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.05, 5.52]
12 Adverse events: 2. Specific: Mean (SD) weight increase in kg Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

12.1 short term	1	640	Mean Difference (IV, Random, 95% CI)	0.2 [‐0.35, 0.75]
13 Adverse events: 3. Movement disorder Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 any extra pyramidal symptoms ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.59, 1.88]
13.2 participants requiring anti‐cholinergic drugs ‐ short term	2	690	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.66, 1.60]
13.3 tardive dyskinesia ‐ short term	1	640	Risk Ratio (M‐H, Random, 95% CI)	9.06 [0.49, 167.52]
14 Adverse events: Mean (SD) change in movement disorder rating scales Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

14.1 AIMS	1	50	Mean Difference (IV, Random, 95% CI)	1.16 [‐1.23, 3.55]
14.2 BARS	1	50	Mean Difference (IV, Random, 95% CI)	0.16 [‐0.65, 0.97]
14.3 SAS	1	50	Mean Difference (IV, Random, 95% CI)	‐0.55 [‐3.71, 2.61]

Comparison 3. RISPERIDONE DEPOT vs ORAL RISPERIDONE

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Comparison 4. RISPERIDONE DEPOT vs ORAL QUETIAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Leaving the study early: 1. Any reason Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 long term	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.74, 0.95]
2 Leaving the study early: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 due to relapse ‐ long term	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.40, 0.73]
3 Adverse events: 1. General Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 any	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.89, 1.09]
3.2 serious	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.62, 1.13]
3.3 death	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.26, 9.14]
4 Adverse events: 2. Specifc Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 psychiatric symptoms	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.84, 1.19]
4.2 prolactin related	1	666	Risk Ratio (M‐H, Random, 95% CI)	3.07 [1.13, 8.36]
4.3 hyperprolactinaemia	1	666	Risk Ratio (M‐H, Random, 95% CI)	8.81 [3.53, 21.96]
4.4 serious psychiatric symptoms	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.58, 1.16]
4.5 weight increase	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.63, 1.99]
4.6 headache	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.64, 2.26]
4.7 fatigue/somnolence	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.07, 0.38]
5 Adverse events: 2. Specific: Mean (SD) weight increase in kg Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

5.1 long term	1	666	Mean Difference (IV, Random, 95% CI)	1.25 [0.25, 2.25]
6 Adverse events: 3. Movement disorder Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 any extra pyramidal symptom	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.83 [1.07, 3.15]
6.2 tremor	1	666	Risk Ratio (M‐H, Random, 95% CI)	5.12 [1.13, 23.20]
6.3 tardive dyskinesia	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.04, 3.27]
6.4 dystonia	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.05, 5.62]
6.5 parkinsonism	1	666	Risk Ratio (M‐H, Random, 95% CI)	2.56 [1.01, 6.52]
6.6 hyperkinesia	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.66 [0.70, 3.96]

Comparison 4. RISPERIDONE DEPOT vs ORAL QUETIAPINE

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Comparison 5. RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Relapse (any reason) Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 long term	1	349	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.83, 1.33]
2 Global state: 3. Mean time in remission (days) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 long term	1	348	Mean Difference (IV, Random, 95% CI)	16.80 [‐43.59, 77.19]
3 Mental state: 1. Average change scores (PANSS, high score = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 long term	1	349	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐3.15, 2.95]
4 Leaving the study early: 1. Any reason Show forest plot	2	723	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.30]

4.1 long term	2	723	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.30]
5 Leaving the study early: 2. Specific Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 adverse events	2	723	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.05, 3.55]
5.2 insufficient response	1	349	Risk Ratio (M‐H, Random, 95% CI)	1.30 [0.29, 5.70]
5.3 withdrawn consent	2	723	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.67, 1.52]
5.4 due to relapse	1	374	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.36, 1.06]
5.5 loss to follow‐up	1	349	Risk Ratio (M‐H, Random, 95% CI)	1.75 [0.83, 3.68]
6 Adverse events: 1. General Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 any	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.14]
6.2 serious	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.66, 1.39]
6.3 death	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.13, 7.36]
7 Adverse events: 2. Specific Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 anxiety	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.75, 1.94]
7.2 depression	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.85, 2.90]
7.3 psychosis	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.69, 1.56]
7.4 psychiatric symptoms	1	374	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.60, 1.09]
7.5 serious psychiatric symptoms	1	374	Risk Ratio (M‐H, Random, 95% CI)	0.75 [0.27, 2.08]
7.6 schizophrenia	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.63, 1.64]
7.7 prolactin related	2	729	Risk Ratio (M‐H, Random, 95% CI)	9.91 [2.78, 35.29]
7.8 hyperprolactinaemia	1	374	Risk Ratio (M‐H, Random, 95% CI)	12.13 [0.76, 193.65]
7.9 weight increase	1	374	Risk Ratio (M‐H, Random, 95% CI)	1.57 [0.38, 6.45]
7.10 nausea/vomiting	1	349	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.64, 2.43]
7.11 gastrointestinal	1	374	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.14, 0.55]
7.12 decreased appetite	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.78 [1.00, 3.16]
7.13 diarrhoea	1	355	Risk Ratio (M‐H, Random, 95% CI)	0.62 [0.31, 1.24]
7.14 headache	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.46, 1.65]
7.15 insomnia	1	355	Risk Ratio (M‐H, Random, 95% CI)	0.91 [0.65, 1.27]
7.16 upper resp. tract infection	1	355	Risk Ratio (M‐H, Random, 95% CI)	0.38 [0.16, 0.89]
7.17 pyrexia	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.16 [0.69, 1.97]
7.18 nasopharyngitis	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.58, 2.10]
7.19 dizziness	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.89 [1.00, 3.58]
7.20 glucose related	1	355	Risk Ratio (M‐H, Random, 95% CI)	1.11 [0.58, 2.10]
8 Adverse events: 2. Specific 12. Mean (SD) weight increase in kg Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

8.1 long term	1	355	Mean Difference (IV, Random, 95% CI)	1.0 [‐0.42, 2.42]
9 Adverse events: 3. Movement disorder Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 any extra pyramidal symptoms	2	729	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.91, 1.55]
9.2 tremor	1	355	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.65, 1.41]
9.3 akathisia	1	355	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.55, 1.76]

Comparison 5. RISPERIDONE DEPOT vs ORAL ARIPIPRAZOLE

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Comparison 6. RISPERIDONE DEPOT vs ORAL OLANZAPINE

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: 1. Average change scores (PANNS, high score = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 total ‐ short term	1	377	Mean Difference (IV, Random, 95% CI)	0.90 [‐2.25, 4.05]
1.2 total ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	0.10 [‐3.96, 4.16]
1.3 positive symptoms ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐1.61, 1.01]
1.4 negative symptoms ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	0.10 [‐1.28, 1.48]
1.5 disorganised thoughts ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	‐0.30 [‐1.34, 0.74]
1.6 hostility/excitement ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	0.20 [‐0.60, 1.00]
1.7 anxiety/depression ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	0.30 [‐0.46, 1.06]
2 Leaving the study early: 1. Any reason Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 long term	1	618	Risk Ratio (M‐H, Random, 95% CI)	1.32 [1.10, 1.58]
3 Leaving the study early: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 adverse events	1	547	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.28, 1.77]
3.2 insufficient response	1	547	Risk Ratio (M‐H, Random, 95% CI)	0.81 [0.49, 1.35]
3.3 withdrawn consent	1	547	Risk Ratio (M‐H, Random, 95% CI)	2.54 [1.56, 4.16]
3.4 due to weight gain	1	547	Risk Ratio (M‐H, Random, 95% CI)	0.24 [0.03, 2.07]
4 Adverse events: 1. General Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 serious	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.80, 1.51]
4.2 death	1	618	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.06, 1.55]
5 Adverse events: 2. Specific Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 agitation	1	532	Risk Ratio (M‐H, Random, 95% CI)	1.98 [1.06, 3.68]
5.2 anxiety	1	532	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.58, 1.31]
5.3 depression	1	532	Risk Ratio (M‐H, Random, 95% CI)	1.45 [0.99, 2.12]
5.4 psychosis	1	532	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.87, 1.52]
5.5 impotence/ejaculation failure	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.17, 8.56]
5.6 galactorrhoea	1	547	Risk Ratio (M‐H, Random, 95% CI)	3.04 [0.59, 15.52]
5.7 serious psychiatric symptoms	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.64, 1.59]
5.8 serious anxiety	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.42 [0.48, 4.16]
5.9 suicide attempt	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.35 [0.56, 3.27]
5.10 serious injury	1	547	Risk Ratio (M‐H, Random, 95% CI)	2.02 [0.49, 8.39]
5.11 weight increase	1	547	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.42, 0.75]
5.12 headache	1	532	Risk Ratio (M‐H, Random, 95% CI)	1.56 [0.81, 3.01]
5.13 insomnia	1	532	Risk Ratio (M‐H, Random, 95% CI)	4.59 [2.61, 8.07]
5.14 fatigue/somnolence	1	532	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.35, 1.41]
5.15 nasopharyngitis	1	532	Risk Ratio (M‐H, Random, 95% CI)	1.17 [0.61, 2.21]
5.16 diabetes mellitus	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.08, 19.32]
5.17 hyperglycaemia	1	494	Risk Ratio (M‐H, Random, 95% CI)	1.0 [0.25, 3.95]
5.18 hypoglycaemia	1	547	Risk Ratio (M‐H, Random, 95% CI)	0.40 [0.02, 9.89]
6 Adverse events: 3. Movement disorder Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 any extra pyramidal symptoms	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.67 [1.19, 2.36]
6.2 tremor	1	547	Risk Ratio (M‐H, Random, 95% CI)	2.29 [1.04, 5.06]
6.3 tardive dyskinesia	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.17, 8.56]
6.4 hypertonia	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.35 [0.56, 3.27]
6.5 dystonia	1	547	Risk Ratio (M‐H, Random, 95% CI)	6.07 [0.29, 125.82]
6.6 hyperkinesia	1	547	Risk Ratio (M‐H, Random, 95% CI)	2.02 [1.01, 4.06]
6.7 requiring antiparkinson drugs	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.26 [1.02, 1.56]

Comparison 6. RISPERIDONE DEPOT vs ORAL OLANZAPINE

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Comparison 7. RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: 1. Relapse (any reason) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 vs aripiprazole ‐ long term	1	349	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.83, 1.33]
1.2 vs general oral antipsychotics ‐ long term	1	63	Risk Ratio (M‐H, Random, 95% CI)	2.13 [0.84, 5.43]
2 Mental state: 1. Average change scores (PANSS, high score = worse) 1. total Show forest plot	4		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 vs oral risperidone (non ITT data) ‐ short term	2	591	Mean Difference (IV, Random, 95% CI)	1.05 [‐0.77, 2.88]
2.2 vs olanzapine ‐ short term	1	377	Mean Difference (IV, Random, 95% CI)	0.90 [‐2.25, 4.05]
2.3 vs olanzapine ‐ long term	1	361	Mean Difference (IV, Random, 95% CI)	0.10 [‐3.96, 4.16]
2.4 vs aripiprazole ‐ long term	1	349	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐3.15, 2.95]
3 Leaving the study early: 1. Any reason Show forest plot	7		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 vs aripiprazole	2	723	Risk Ratio (M‐H, Random, 95% CI)	0.83 [0.53, 1.30]
3.2 vs quetiapine	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.74, 0.95]
3.3 vs oral risperidone	2	690	Risk Ratio (M‐H, Random, 95% CI)	1.28 [0.92, 1.79]
3.4 vs any new generation antipsychotic	1	77	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.55, 0.95]
3.5 vs olanzapine	1	618	Risk Ratio (M‐H, Random, 95% CI)	1.32 [1.10, 1.58]
3.6 vs any oral antipsychotic	1	382	Risk Ratio (M‐H, Random, 95% CI)	1.25 [0.93, 1.68]
4 Adverse events: 1. Death Show forest plot	5		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 vs olanzapine	1	618	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.06, 1.55]
4.2 vs oral risperidone	1	640	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.20]
4.3 vs any oral antipsychotic	1	382	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.14, 7.10]
4.4 vs aripiprazole	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.13, 7.36]
4.5 vs quetiapine	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.26, 9.14]
5 Adverse events: 1. General: a. any Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

5.1 vs aripiprazole	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.14]
5.2 vs oral risperidone	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.04 [0.91, 1.18]
5.3 vs quetiapine	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.89, 1.09]
6 Adverse events: 1. General: b. serious Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 vs quetiapine	1	666	Risk Ratio (M‐H, Random, 95% CI)	0.84 [0.62, 1.13]
6.2 vs aripiprazole	2	729	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.66, 1.39]
6.3 vs olanzapine	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.10 [0.80, 1.51]
7 Adverse events: 2. Movement disorder: a. any extra pyramidal symptoms Show forest plot	4		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 vs aripiprazole	2	729	Risk Ratio (M‐H, Random, 95% CI)	1.19 [0.91, 1.55]
7.2 vs quetiapine	1	666	Risk Ratio (M‐H, Random, 95% CI)	1.83 [1.07, 3.15]
7.3 vs olanzapine	1	547	Risk Ratio (M‐H, Random, 95% CI)	1.67 [1.19, 2.36]
7.4 vs oral risperidone	1	640	Risk Ratio (M‐H, Random, 95% CI)	1.05 [0.59, 1.88]

Comparison 7. RISPERIDONE DEPOT vs ALL ORAL ANTIPSYCHOTICS (PRIMARY OUTCOMES)

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Comparison 8. RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global State: 1. CGI‐S mean change from baseline (high score = worse) Show forest plot	2	1326	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.26, 0.11]

1.1 medium term	2	1326	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.26, 0.11]
2 Global state: 2. Schedule for Deficit Syndrome (SDS) scale (mean change from baseline, high score = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

2.1 medium term	1	913	Mean Difference (IV, Random, 95% CI)	0.10 [‐0.29, 0.49]
3 Mental state: 1. PANSS scores (high score = worse) ‐ medium term Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

3.1 total mean change to endpoint (ITT and per protocol data)*	2	1326	Mean Difference (IV, Random, 95% CI)	1.12 [‐2.79, 5.02]
3.2 positive symptoms score change to endpoint	2	1326	Mean Difference (IV, Random, 95% CI)	0.66 [‐1.39, 2.71]
3.3 negative symptoms score change to endpoint (ITT data)	2	1326	Mean Difference (IV, Random, 95% CI)	0.06 [‐0.47, 0.59]
3.4 disorganised thoughts score change to endpoint (ITT data)	2	1326	Mean Difference (IV, Random, 95% CI)	0.02 [‐0.55, 0.59]
3.5 uncontrolled hostility/excitement score change to endpoint (ITT data)	2	1326	Mean Difference (IV, Random, 95% CI)	‐0.04 [‐0.50, 0.41]
3.6 anxiety/depression score change to endpoint (ITT data)	2	1326	Mean Difference (IV, Random, 95% CI)	0.01 [‐0.67, 0.69]
4 Mental state: 2. Improved by 30% in total PANSS score (ITT data) Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

4.1 medium term	2	1326	Risk Ratio (M‐H, Random, 95% CI)	1.01 [0.83, 1.23]
5 General functioning: Personal and Social Performance (PSP) scale (high score = better) Show forest plot	2	1326	Mean Difference (IV, Random, 95% CI)	0.65 [‐0.69, 1.98]

5.1 mean endpoint ‐ medium term	2	1326	Mean Difference (IV, Random, 95% CI)	0.65 [‐0.69, 1.98]
6 Leaving the study early: 1. Any reason Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

6.1 Lack of efficacy ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.71 [0.29, 1.75]
6.2 Lack of efficacy ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.60 [0.45, 0.81]
6.3 Adverse events ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.68 [0.28, 1.65]
6.4 Adverse events ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.88 [0.53, 1.48]
6.5 Patient choice/withdrawn consent ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.22, 1.71]
6.6 Patient choice/withdrawn consent ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.83, 1.61]
6.7 Lost to follow‐up ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	1.61 [0.93, 2.79]
6.8 Lost to follow‐up ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.87 [0.39, 1.91]
6.9 Pregnancy ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.26 [0.03, 2.32]
6.10 Pregnancy ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.06, 16.32]
6.11 Death ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.01, 4.25]
6.12 Other ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.45, 1.32]
6.13 Other ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	1.09 [0.67, 1.78]
6.14 Any reason ‐ medium term	2	1672	Risk Ratio (M‐H, Random, 95% CI)	0.77 [0.51, 1.17]
6.15 Any reason ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.75, 0.97]
7 Adverse events: 1. General Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 overall rate ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	1.20 [0.33, 4.42]
7.2 overall rate ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.58, 0.95]
7.3 worsening of schizophrenia ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	0.82 [0.40, 1.69]
7.4 worsening of psychiatric disorders ‐ medium term	1	1214	Risk Ratio (M‐H, Random, 95% CI)	0.54 [0.22, 1.34]
7.5 death ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.14, 6.54]
7.6 death ‐ long term	1	749	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.01, 4.25]
8 Adverse events: 2. Specific Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

8.1 overall rate ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	0.96 [0.86, 1.08]
8.2 overall rate ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.95, 1.11]
8.3 insomnia ‐ medium term	1	1214	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.49, 1.05]
8.4 insomnia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.71, 1.40]
8.5 psychotic disorder ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.86 [0.59, 1.24]
8.6 worsening of schizophrenia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.49, 1.16]
8.7 anxiety ‐ medium term	1	1214	Risk Ratio (M‐H, Random, 95% CI)	0.50 [0.26, 0.96]
8.8 anxiety ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.49 [1.01, 2.20]
8.9 headache ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.78, 1.87]
8.10 constipation ‐ medium term	1	1214	Risk Ratio (M‐H, Random, 95% CI)	3.79 [1.42, 10.08]
8.11 injection site pain ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.07, 0.38]
8.12 somnolence ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.21, 1.49]
8.13 weight gain (proportion of participants with >7% increase) ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	1.12 [0.72, 1.75]
8.14 tachycardia ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	1.03 [0.26, 4.06]
8.15 tachycardia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.11, 1.05]
9 Adverse events: 3. Prolactin related Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

9.1 amenorrhoea ‐ medium term	2	784	Risk Ratio (M‐H, Random, 95% CI)	1.78 [0.24, 13.02]
9.2 galactorrhoea ‐ medium term	1	271	Risk Ratio (M‐H, Random, 95% CI)	0.37 [0.02, 8.92]
9.3 hyperprolactinaemia ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	5.13 [0.60, 43.60]
9.4 erectile dysfunction ‐ medium term	1	701	Risk Ratio (M‐H, Random, 95% CI)	0.80 [0.18, 3.53]
9.5 increase in serum prolactin ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.35, 1.48]
9.6 amenorrhoea‐galactorrhoea syndrome ‐ medium term	1	271	Risk Ratio (M‐H, Random, 95% CI)	3.3 [0.14, 80.29]
9.7 any prolactin related ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	1.02 [0.61, 1.71]
9.8 proportion of male participants with abnormally high prolactin ‐ long term	1	424	Risk Ratio (M‐H, Random, 95% CI)	1.68 [1.32, 2.14]
9.9 proportion of female participants with abnormally high prolactin ‐ long term	1	294	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.95, 1.55]
10 Adverse events: 4. Movement disorder Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

10.1 akathisia ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	1.51 [0.98, 2.31]
10.2 tremor ‐ medium term	1	452	Risk Ratio (M‐H, Random, 95% CI)	1.71 [1.07, 2.74]
10.3 tardive dyskinesia ‐ medium term	1	1214	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.06, 15.90]
10.4 requiring use of anti‐EPS medication ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	1.46 [1.18, 1.80]
10.5 hyperkinesia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.66 [1.00, 2.73]
10.6 neuroleptic malignant syndrome ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.40]
11 Adverse events: 5. Body weight (mean increase) Show forest plot	3	2350	Mean Difference (IV, Random, 95% CI)	0.18 [‐0.36, 0.72]

11.1 medium term	2	1666	Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.38, 0.24]
11.2 long term	1	684	Mean Difference (IV, Random, 95% CI)	1.0 [0.13, 1.87]
12 Adverse events: 6. Mean prolactin level increase (ng/mL) Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

12.1 female participants	2	807	Mean Difference (IV, Random, 95% CI)	‐3.40 [‐12.65, 5.85]
12.2 male participants	2	1125	Mean Difference (IV, Random, 95% CI)	‐0.43 [‐5.88, 5.03]
13 Adverse events: 7. Glucose related Show forest plot	3		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

13.1 increased blood glucose ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.54 [0.44, 5.43]
13.2 hyperglycaemia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.37 [0.31, 6.09]
13.3 diabetes mellitus ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	4.12 [0.46, 36.68]
13.4 glycosuria ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.40]
13.5 ketonuria ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.40]
13.6 urine ketone body present ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.01, 8.40]
13.7 hypoglycaemia ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	3.09 [0.13, 75.59]
13.8 any glucose related ‐ medium term	2	1666	Risk Ratio (M‐H, Random, 95% CI)	1.76 [0.52, 5.98]
13.9 any glucose related ‐ long term	1	747	Risk Ratio (M‐H, Random, 95% CI)	1.80 [0.77, 4.25]
14 Adverse events: 8. Injection site pain (mean (sd) Visual Analogue Scale score (0‐100mm)) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

14.1 at baseline	1	747	Mean Difference (IV, Random, 95% CI)	1.80 [‐0.24, 3.84]
14.2 at endpoint	1	747	Mean Difference (IV, Random, 95% CI)	0.0 [‐1.07, 1.07]

Comparison 8. RISPERIDONE DEPOT vs ATYPICAL DEPOT ANTIPSYCHOTICS (PALIPERIDONE PALMITATE)

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Comparison 9. RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: 1. Total endpoint scores (PANNS, high score = worse) Show forest plot	1		Mean Difference (IV, Random, 95% CI)	Subtotals only

1.1 short term	1	49	Mean Difference (IV, Random, 95% CI)	0.70 [‐8.12, 9.52]
1.2 medium term	1	46	Mean Difference (IV, Random, 95% CI)	‐0.10 [‐9.02, 8.82]
1.3 long term	1	43	Mean Difference (IV, Random, 95% CI)	1.80 [‐10.04, 13.64]
2 Leaving the study early Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

2.1 before beginning assigned treatment	1	62	Risk Ratio (M‐H, Random, 95% CI)	7.50 [1.00, 56.44]
2.2 by 6 months	1	62	Risk Ratio (M‐H, Random, 95% CI)	3.05 [1.12, 8.31]
2.3 due to increased psychiatric symptoms	1	62	Risk Ratio (M‐H, Random, 95% CI)	2.81 [0.31, 25.58]
2.4 due to EPS effects	1	62	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.01, 7.40]
2.5 due to weight gain and hypertension	1	62	Risk Ratio (M‐H, Random, 95% CI)	2.82 [0.12, 66.62]
2.6 due to participant preference	1	62	Risk Ratio (M‐H, Random, 95% CI)	0.94 [0.06, 14.33]
3 Hospitalisation by 6 months Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

3.1 medium term	1	62	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.11, 3.48]
4 Adverse events: 1. Continuous outcomes (skew) Show forest plot			Other data	No numeric data

4.1 Change in BMI ‐ short term (skew)			Other data	No numeric data
4.2 Change in BMI ‐ medium term (skew)			Other data	No numeric data
4.3 Change in BMI ‐ long term (skew)			Other data	No numeric data
4.4 Prolactin endpoint levels (ng/mL) ‐ short term (skew)			Other data	No numeric data
4.5 Prolactin endpoint levels (ng/mL) ‐ medium term (skew)			Other data	No numeric data
4.6 Prolactin endpoint levels (ng/mL) ‐ long term (skew)			Other data	No numeric data
5 Adverse events: 2. Sexual experiencesm, total endpoint (ASEX, high score = worse) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

5.1 short term	1	44	Mean Difference (IV, Fixed, 95% CI)	1.70 [‐1.26, 4.66]
5.2 medium term	1	41	Mean Difference (IV, Fixed, 95% CI)	1.30 [‐2.30, 4.90]
5.3 long term	1	40	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐4.08, 3.88]

Comparison 9. RISPERIDONE DEPOT vs TYPICAL DEPOT ANTIPSYCHOTICS

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