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. 2016 Apr 14;2016(4):CD004161. doi: 10.1002/14651858.CD004161.pub2

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 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) 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) 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) 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 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) 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) 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 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 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) 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) 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) 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 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 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 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 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 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]