Depot risperidone for schizophrenia

Prakash Hosalli; John M Davis

doi:10.1002/14651858.CD004161

Risperidona de depósito para la esquizofrenia

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Referencias

Referencias de los estudios incluidos en esta revisión

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otras referencias

Chue P, Eerdekens M, Augustyns I, Lachaux B, Molcan P, Eriksson L, Pretorius H, David A. Efficacy and safety of long‐acting risperidone microspheres and risperidone oral tables. Schizophrenia Research (Abstracts of the 11th Biennial Winter Workshop on Schizophrenia) 2002;3(Suppl 1):174.

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Kane J, Eerdekens M, Keith SJ, Lesem M, Karcher K, Lindenmayer JP. Efficacy and safety of risperdal consta, the long‐acting injection risperidone formulation. International Journal of Neuropsychopharmacology (Abstracts of the 23rd Congress of the Collegium Internationale Neuro‐Psychopharmacologicum; 2002 Jun 23‐27; Montreal, Canada) 2002;5(Suppl 1):S188.

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Kane JM, Eerdekens M, Keith SJ, Lesem M, Karcher k, Lindenmayer JP. Long‐acting injectable risperidone: Efficacy and safety. European Neuropsychopharmacology: The Journal of the European College of Neuropsychopharmacology (15th ECNP Congress; October 5‐9, 2002, Barcelona‐Spain 2002;12(Supplement 3):S325.

Kane JM, Eerdekens M, Lindenmayer JP, Keith SJ, Lesem M, Karcher K. Long‐acting injectable risperidone: efficacy and safety of the first long‐acting atypical antipsychotic. American Journal of Psychiatry 2003;160(6):1125‐32.

Referencias de los estudios excluidos de esta revisión

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Bouchard RH, Merette C, Pourcher E, Demers MF, Villeneuve J, Roy Gagnon MH, Gauthier Y, Cliche D, Labelle A, Filteau MJ, Roy MA, Maziade M, The Quebec Schizophrenia Study Group. Longitudinal comparative study of risperidone and conventional neuroleptics for treating patients with schizophrenia. Journal of Clinical Psychopharmacology 2000;20(3):295‐304. [MEDLINE: 20289861]

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Eerdekens M, Fleischhacker WW, Xie Y, Gefvert O. Long‐term safety of long‐acting risperidone microspheres. Schizophrenia Research (Abstracts of the 11th Biennial Winter Workshop on Schizophrenia) 2002;3(Suppl 1):174.

Fleischhacker WW, Eerdekens M, Xie Y, Beauclair L, Sauret H, Chrzanowski W, Martin S, Gefvert O. Long‐term saftey and efficacy of risperdal consta(TM) a long‐acting injection formulation of risperidone. ACNP, Hawaii, USA, December 2001 (Promotional slides on file from Janssen‐Cliag UK Ltd)2002.

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Referencias de los estudios en espera de evaluación

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Nasrallah H, Duchesne I, Mehnert A, Janagap C. Long‐acting risperidone improves quality of life. XIIth World Congress of Psychiatry; 2002 Aug 24‐29; Yokohama, Japan2002.

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Referencias adicionales

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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Chue 2002

Methods	Allocation: randomised, stratified by PANSS, ESRS, depot in last 6/12, dose of risperidone at end of run in. Blindness: double.* Duration: 12 weeks (preceded by 8 week non random run‐in). Design: parallel.
Participants	Diagnosis: schizophrenia (DSM IV). N=640.** Sex: M= 415, F=225. Age: mean ˜40 years (SD˜15), range 18‐65. History: PANSS score >50, but ˜47% "not ill or only mildly ill" on CGI, stabilized 8/52 on oral resperidone. Exclusions: not described.
Interventions	1. Risperidone depot: 25, 50 or 75mg, 2 weekly + daily placebo tablets. N=319. 2. Risperidone oral: 2, 4 or 6mg/day + placebo injections 2 weekly. N=321.
Outcomes	Mental state: PANSS. Leaving the study early. Adverse events: others as reported by participants. Unable to use ‐ Global state: CGI (data on subgroups only). Adverse events: ESRS (no usable data). Body weight: change (no usable data). Pain at injection site (no usable data). Physiological tests: including ECG (no usable data).
Notes	* blindness was maintained with different doses by using the same volume of diluent. ** Numbers randomised not consistent in presentations (426 vs 640).
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Kane 2002

Methods	Allocation: randomised, not described. Blindness: double, identical injections.* Duration: 12 weeks (preceded by up to 4mg risperidone/day for 1 week). Design: parallel.
Participants	Diagnosis: schizophrenia (DSM IV). N=400. Age: mean˜37 years (SD˜20). Sex: 301 men, 99 women. History: PANSS score 60‐120. Exclusions: not described.
Interventions	1. Risperidone depot: 25mg 2 weekly + 2mg/day oral risperidone for 3/52. N=99. 2. Risperidone depot: 50mg 2 weekly + 4mg/day oral risperidone for 3/52. N=100. 3. Risperidone depot: 75mg 2 weekly + 6mg/day oral risperidone for 3/52. N=100. 4. Placebo injections: 2 weekly + placebo tablets for first 3/52. N=100.
Outcomes	Global state: CGI. Mental state: 20% reduction PANSS. Adverse events: ESRS and others as reported by participants. Body weight: change. Pain at injection site. Physiological tests: including ECG. Unable to use ‐ Mental state: change PANSS (no SD).
Notes	* Unclear how blindness was maintained as it was necessary to inject different doses and therefore number of millilitres.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

DSM IV: Diagnostic and Statistical Mannual version 1V.
ESRS: Extrapyramidal Symptom Rating Scale.
N: Number.
PANSS: Positive And Negative Symptom Scale.
SD: Standard Deviation.

Characteristics of excluded studies [ordered by study ID]

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Study	Reason for exclusion
Bouchard 2000	Allocation: randomised. Participants: people with schizophrenia. Interventions: oral risperidone versus conventional antipsychotic drugs, not depot risperidone.
Eerdekens 2002 a	Allocation: not randomised, open label.
Eerdekens 2002 b	Allocation: not randomised, review.
Gallhofer 1995	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Gefvert 2001	Allocation: non‐randomised trial.
Kogeorgos 1995	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Lindenmayer 1995	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Littrell 1999	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Ritchie 1999	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Robinson 2000	Allocation: randomised. Participants: people with schizophrenia. Interventions: not depot risperidone.
Vaughan 2000	Allocation: randomised. Participants: people with schizophrenia. Interventions: not a drug trial, study of effect of community treatment orders.

Data and analyses

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Comparison 1. RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Mental state: Exacerbation of specific symptoms Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 1 Mental state: Exacerbation of specific symptoms.
1.1 anxiety	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.32, 1.05]
1.2 agitation	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.39, 0.92]
1.3 hallucinations	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.47, 3.22]
1.4 nervousness	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.12, 1.25]
1.5 psychosis	1	400	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 2 Leaving the study early: 1. Any reason (by time period).
2.1 very early on (<1 injection)	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.55, 3.08]
2.2 by 12 weeks	1	400	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.3 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 3 Leaving the study early: 2. Any reason (by doses).
3.1 all doses risperidone depot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.63, 0.88]
3.2 25mg risperidone depot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.59, 0.94]
3.3 50mg risperidone depot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.59, 0.93]
3.4 75mg risperidone depot	1	198	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.4 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 4 Leaving the study early: 3. Because of insufficient response (by doses).
4.1 all three doses	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.36, 0.79]
4.2 25mg depot risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.45, 1.17]
4.3 50mg depot risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.27, 0.83]
4.4 75mg depot risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.21, 0.72]
5 Adverse events: 1. General: 1. Death by 12 weeks Show forest plot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.00, 2.65]
Open in figure viewer Analysis 1.5 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 5 Adverse events: 1. General: 1. Death by 12 weeks.
6 Adverse events: 1. General: 2. Severe adverse event (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.6 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 6 Adverse events: 1. General: 2. Severe adverse event (by doses).
6.1 any dose risperidone depot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.38, 0.93]
6.2 25mg risperidone depot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.30, 1.04]
6.3 50mg risperidone depot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.32, 1.06]
6.4 75mg risperidone depot	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.36, 1.15]
7 Adverse events: 1. General: 3. Adverse event necessitating withdrawal from study (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.7 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 7 Adverse events: 1. General: 3. Adverse event necessitating withdrawal from study (by doses).
7.1 any dose risperidone depot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.00 [0.54, 1.84]
7.2 25mg risperidone depot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.91 [0.42, 1.96]
7.3 50mg risperidone depot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.45, 2.02]
7.4 75mg risperidone depot	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.56, 2.35]
8 Adverse events: 2. Specific: 1. Cardiovascular Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.8 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 8 Adverse events: 2. Specific: 1. Cardiovascular.
8.1 dizziness	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.46 [0.62, 3.43]
8.2 tachycardia	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.32 [0.11, 0.98]
9 Adverse events: 2. Specific: 2. Gastrointestinal Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.9 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 9 Adverse events: 2. Specific: 2. Gastrointestinal.
9.1 constipation	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	6.17 [0.84, 45.46]
9.2 diarrhoea	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.23, 3.20]
9.3 nausea	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.39, 2.76]
9.4 vomiting	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.23, 1.57]
10 Adverse events: 2. Specific: 3. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by do Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.10 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 10 Adverse events: 2. Specific: 3. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by do.
10.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.38 [0.73, 7.78]
10.2 25mg risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.30, 5.74]
10.3 50mg risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	2.54 [0.69, 9.29]
10.4 75mg risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	3.27 [0.93, 11.51]
11 Adverse events: 2. Specific: 4. Movement disorders: b. Hyperkinesia (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.11 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 11 Adverse events: 2. Specific: 4. Movement disorders: b. Hyperkinesia (by doses).
11.1 all doses of risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [0.60, 4.84]
11.2 25mg risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.09, 2.64]
11.3 50mg risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [0.68, 6.73]
11.4 75mg of risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	2.45 [0.79, 7.55]
12 Adverse events: 2. Specific: 5. Movement disorders: c. Hypertonia (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.12 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 12 Adverse events: 2. Specific: 5. Movement disorders: c. Hypertonia (by doses).
12.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.47, 3.22]
12.2 25mg risperidone	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.22, 2.86]
12.3 50mg risperidone	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.28, 3.19]
12.4 75mg risperidone	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [0.70, 5.53]
13 Adverse events: 2. Specific: 6. Pain Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.13 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 13 Adverse events: 2. Specific: 6. Pain.
13.1 headache	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [0.88, 2.80]
13.2 pain ‐ unspecified	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.48, 4.00]
14 Adverse events: 2. Specific: 7. Salivation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.14 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 14 Adverse events: 2. Specific: 7. Salivation.
14.1 decreased	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.92 [0.37, 22.76]
14.2 increased	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.92 [0.37, 22.76]
15 Adverse events: 2. Specific: 8. Sleep disturbances Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.15 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 15 Adverse events: 2. Specific: 8. Sleep disturbances.
15.1 insomnia	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.60, 1.82]
15.2 somnolence	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [0.69, 7.45]
16 Adverse events: 2. Specific: 9. Weight gain Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.16 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 16 Adverse events: 2. Specific: 9. Weight gain.
16.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.11 [0.48, 9.18]
16.2 25mg risperidone	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	2.47 [0.49, 12.45]
16.3 50mg risperidone	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	1.90 [0.36, 10.16]
16.4 75mg risperidone	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [0.37, 10.46]
17 Adverse events: 2. Specific: 10. Others Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.17 Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 17 Adverse events: 2. Specific: 10. Others.
17.1 coughing	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.97 [0.32, 2.95]
17.2 fatigue	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	8.82 [0.53, 147.05]
17.3 injury	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.38 [0.13, 1.10]
17.4 rhinitis	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.01 [0.47, 2.17]

Open in table viewer

Comparison 2. RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Moderate to severly ill at end of study period (CGI rating) Show forest plot	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.92, 1.22]
Open in figure viewer Analysis 2.1 Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 1 Global state: Moderate to severly ill at end of study period (CGI rating).
2 Mental state: 1. Average endpoint scores (PANSS total, non ITT data, high score = poor) Show forest plot	1	541	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.91, 2.91]
Open in figure viewer Analysis 2.2 Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 2 Mental state: 1. Average endpoint scores (PANSS total, non ITT data, high score = poor).
3 Mental state: 2. Average change scores (PANSS, non ITT data, high score = good) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.3 Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 3 Mental state: 2. Average change scores (PANSS, non ITT data, high score = good).
3.1 PANSS total	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐2.84, 1.04]
3.2 PANSS positive	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.86, 0.26]
3.3 PANSS negative	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.93, 0.73]
4 Poor compliance Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.4 Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 4 Poor compliance.
4.1 <4 injections or "major protocol violation"	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.81, 1.67]
4.2 leaving the study early for any reason	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.90, 1.78]
4.3 withdrew consent or "non‐compliance" or lost to follow up	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.68, 2.19]
5 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.5 Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 5 Adverse events.
5.1 death	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.20]
5.2 adverse event leading to withdrawal from study	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.62, 2.35]
5.3 any adverse event reported	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.91, 1.18]

Analysis 1.1

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 1 Mental state: Exacerbation of specific symptoms.

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Analysis 1.2

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) 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 (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 3 Leaving the study early: 2. Any reason (by doses).

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Analysis 1.4

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) 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 (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 5 Adverse events: 1. General: 1. Death by 12 weeks.

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Analysis 1.6

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 6 Adverse events: 1. General: 2. Severe adverse event (by doses).

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Analysis 1.7

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 7 Adverse events: 1. General: 3. Adverse event necessitating withdrawal from study (by doses).

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Analysis 1.8

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 8 Adverse events: 2. Specific: 1. Cardiovascular.

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Analysis 1.9

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 9 Adverse events: 2. Specific: 2. Gastrointestinal.

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Analysis 1.10

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 10 Adverse events: 2. Specific: 3. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by do.

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Analysis 1.11

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 11 Adverse events: 2. Specific: 4. Movement disorders: b. Hyperkinesia (by doses).

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Analysis 1.12

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 12 Adverse events: 2. Specific: 5. Movement disorders: c. Hypertonia (by doses).

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Analysis 1.13

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 13 Adverse events: 2. Specific: 6. Pain.

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Analysis 1.14

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 14 Adverse events: 2. Specific: 7. Salivation.

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Analysis 1.15

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 15 Adverse events: 2. Specific: 8. Sleep disturbances.

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Analysis 1.16

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 16 Adverse events: 2. Specific: 9. Weight gain.

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Analysis 1.17

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 17 Adverse events: 2. Specific: 10. Others.

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Analysis 2.1

Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 1 Global state: Moderate to severly ill at end of study period (CGI rating).

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Analysis 2.2

Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 2 Mental state: 1. Average endpoint scores (PANSS total, non ITT data, high score = poor).

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Analysis 2.3

Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 3 Mental state: 2. Average change scores (PANSS, non ITT data, high score = good).

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Analysis 2.4

Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 4 Poor compliance.

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Analysis 2.5

Comparison 2 RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day), Outcome 5 Adverse events.

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Comparison 1. RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO

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

1.1 anxiety	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.32, 1.05]
1.2 agitation	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.60 [0.39, 0.92]
1.3 hallucinations	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.47, 3.22]
1.4 nervousness	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.12, 1.25]
1.5 psychosis	1	400	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only

2.1 very early on (<1 injection)	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [0.55, 3.08]
2.2 by 12 weeks	1	400	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only

3.1 all doses risperidone depot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.63, 0.88]
3.2 25mg risperidone depot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.59, 0.94]
3.3 50mg risperidone depot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.74 [0.59, 0.93]
3.4 75mg risperidone depot	1	198	Risk Ratio (M‐H, Fixed, 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, Fixed, 95% CI)	Subtotals only

4.1 all three doses	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.53 [0.36, 0.79]
4.2 25mg depot risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.73 [0.45, 1.17]
4.3 50mg depot risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.48 [0.27, 0.83]
4.4 75mg depot risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.39 [0.21, 0.72]
5 Adverse events: 1. General: 1. Death by 12 weeks Show forest plot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.11 [0.00, 2.65]

6 Adverse events: 1. General: 2. Severe adverse event (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 any dose risperidone depot	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.38, 0.93]
6.2 25mg risperidone depot	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.56 [0.30, 1.04]
6.3 50mg risperidone depot	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.58 [0.32, 1.06]
6.4 75mg risperidone depot	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	0.64 [0.36, 1.15]
7 Adverse events: 1. General: 3. Adverse event necessitating withdrawal from study (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

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

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

9.1 constipation	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	6.17 [0.84, 45.46]
9.2 diarrhoea	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.87 [0.23, 3.20]
9.3 nausea	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.39, 2.76]
9.4 vomiting	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	0.59 [0.23, 1.57]
10 Adverse events: 2. Specific: 3. Movement disorders: a. Extrapyramidal disorder ‐ spontaneously reported (by do Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.38 [0.73, 7.78]
10.2 25mg risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	1.32 [0.30, 5.74]
10.3 50mg risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	2.54 [0.69, 9.29]
10.4 75mg risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	3.27 [0.93, 11.51]
11 Adverse events: 2. Specific: 4. Movement disorders: b. Hyperkinesia (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 all doses of risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.70 [0.60, 4.84]
11.2 25mg risperidone group	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.49 [0.09, 2.64]
11.3 50mg risperidone group	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	2.14 [0.68, 6.73]
11.4 75mg of risperidone group	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	2.45 [0.79, 7.55]
12 Adverse events: 2. Specific: 5. Movement disorders: c. Hypertonia (by doses) Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

12.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.23 [0.47, 3.22]
12.2 25mg risperidone	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	0.79 [0.22, 2.86]
12.3 50mg risperidone	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	0.95 [0.28, 3.19]
12.4 75mg risperidone	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [0.70, 5.53]
13 Adverse events: 2. Specific: 6. Pain Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

13.1 headache	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [0.88, 2.80]
13.2 pain ‐ unspecified	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [0.48, 4.00]
14 Adverse events: 2. Specific: 7. Salivation Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

14.1 decreased	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.92 [0.37, 22.76]
14.2 increased	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.92 [0.37, 22.76]
15 Adverse events: 2. Specific: 8. Sleep disturbances Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

15.1 insomnia	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.60, 1.82]
15.2 somnolence	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.27 [0.69, 7.45]
16 Adverse events: 2. Specific: 9. Weight gain Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

16.1 all doses of depot risperidone	1	400	Risk Ratio (M‐H, Fixed, 95% CI)	2.11 [0.48, 9.18]
16.2 25mg risperidone	1	197	Risk Ratio (M‐H, Fixed, 95% CI)	2.47 [0.49, 12.45]
16.3 50mg risperidone	1	201	Risk Ratio (M‐H, Fixed, 95% CI)	1.90 [0.36, 10.16]
16.4 75mg risperidone	1	198	Risk Ratio (M‐H, Fixed, 95% CI)	1.96 [0.37, 10.46]
17 Adverse events: 2. Specific: 10. Others Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

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

Comparison 1. RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO

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Comparison 2. RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Global state: Moderate to severly ill at end of study period (CGI rating) Show forest plot	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.06 [0.92, 1.22]

2 Mental state: 1. Average endpoint scores (PANSS total, non ITT data, high score = poor) Show forest plot	1	541	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.91, 2.91]

3 Mental state: 2. Average change scores (PANSS, non ITT data, high score = good) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 PANSS total	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐2.84, 1.04]
3.2 PANSS positive	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [‐0.86, 0.26]
3.3 PANSS negative	1	541	Mean Difference (IV, Fixed, 95% CI)	‐0.10 [‐0.93, 0.73]
4 Poor compliance Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 <4 injections or "major protocol violation"	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.16 [0.81, 1.67]
4.2 leaving the study early for any reason	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.27 [0.90, 1.78]
4.3 withdrew consent or "non‐compliance" or lost to follow up	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.22 [0.68, 2.19]
5 Adverse events Show forest plot	1		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 death	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	0.34 [0.01, 8.20]
5.2 adverse event leading to withdrawal from study	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.21 [0.62, 2.35]
5.3 any adverse event reported	1	640	Risk Ratio (M‐H, Fixed, 95% CI)	1.04 [0.91, 1.18]

Comparison 2. RISPERIDONE DEPOT (25, 50 or 75mg/2 weeks) vs ORAL RISPERIDONE (2, 4 or 6mg/day)

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Referencias

Referencias de los estudios incluidos en esta revisión

Chue 2002 {published and unpublished data}

Kane 2002 {published data only}

Referencias de los estudios excluidos de esta revisión

Bouchard 2000 {published data only}

Eerdekens 2002 a {published data only}

Eerdekens 2002 b {published data only}

Gallhofer 1995 {published data only}

Gefvert 2001 {published data only}

Kogeorgos 1995 {published data only}

Lindenmayer 1995 {published data only}

Littrell 1999 {published data only}

Ritchie 1999 {published data only}

Robinson 2000 {published data only}

Vaughan 2000 {published data only}

Referencias de los estudios en espera de evaluación

Nasrallah 2002 {published data only}

Turner 2000 {published data only}

Referencias adicionales

Adams 2001

Altman 1996

Bland 1997

Chouinard 1980

Clarke 2002

Davis 1977

Davis 1986

Divine 1992

Dohrenwend 1980

Egger 1997

Fenton 1997

Geddes 2000

Gulliford 1999

Guy 1976

Jablensky 1992

Janssen 1988

Kay 1987

Kennedy 2000

Leucht 1999

Marder 1994

Marshall 2000

Moher 2001

Regier 1984

Sarfati 1999

Small 1997

Tollefson 1997

Young 1986

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Characteristics of excluded studies [ordered by study ID]

Data and analyses

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Instituciones a las que se accedió previamente

Usuarios institucionales

Instituciones a las que se accedió previamente

Otras opciones de acceso