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Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 1 Mental state: Exacerbation of specific symptoms.
Figuras y tablas -
Analysis 1.1

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 2 Leaving the study early: 1. Any reason (by time period).
Figuras y tablas -
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).

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 4 Leaving the study early: 3. Because of insufficient response (by doses).
Figuras y tablas -
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).

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

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

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).
Figuras y tablas -
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).

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 8 Adverse events: 2. Specific: 1. Cardiovascular.
Figuras y tablas -
Analysis 1.8

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 9 Adverse events: 2. Specific: 2. Gastrointestinal.
Figuras y tablas -
Analysis 1.9

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

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.
Figuras y tablas -
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.

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

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 13 Adverse events: 2. Specific: 6. Pain.
Figuras y tablas -
Analysis 1.13

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 14 Adverse events: 2. Specific: 7. Salivation.
Figuras y tablas -
Analysis 1.14

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 15 Adverse events: 2. Specific: 8. Sleep disturbances.
Figuras y tablas -
Analysis 1.15

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 16 Adverse events: 2. Specific: 9. Weight gain.
Figuras y tablas -
Analysis 1.16

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

Comparison 1 RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO, Outcome 17 Adverse events: 2. Specific: 10. Others.
Figuras y tablas -
Analysis 1.17

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

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).
Figuras y tablas -
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).

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).
Figuras y tablas -
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).

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).
Figuras y tablas -
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).

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

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

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]

Figuras y tablas -
Comparison 1. RISPERIDONE DEPOT (25, 50 or 75mg/2weeks) vs PLACEBO
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]

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