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 low2,3 | |
| 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 low2,5 | |
| 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 low2,6 | |
| *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.