Summary of findings 5. Antidepressant plus antipsychotic compared to placebo for psychotic depression.
| Antidepressant plus antipsychotic compared to placebo for psychotic depression | ||||||
| Patient or population: adults with psychotic depression Setting: at least first week of study in hospital Intervention: antidepressant plus antipsychotic Comparison: placebo | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | №. of participants (studies) | Certainty of evidence (GRADE) | Comments | |
| Risk with placebo | Risk with antidepressant plus antipsychotic | |||||
| Clinical response of depression | Study population | RR 1.86 (1.23 to 2.82) | 148 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b,c | Both studies defined response as reduction in HAMD‐24 ≥ 50% at endpoint | |
| 280 per 1000 | 521 per 1000 (344 to 790) | |||||
| Overall dropouts | Study population | RR 0.75 (0.48 to 1.18) | 148 (2 RCTs) | ⊕⊝⊝⊝ Very lowa,b,d | ||
| 470 per 1000 | 353 per 1000 (226 to 555) | |||||
| Depression remission | See comment | ‐ | ‐ | ‐ | No study reported this outcome | |
| Change in depression severity from baseline | See comment | ‐ | ‐ | ‐ | No study reported this outcome | |
| Quality of life | See comment | ‐ | ‐ | ‐ | No study reported this outcome | |
| Dropouts due to adverse effects | See comment | ‐ | ‐ | ‐ | No study reported this outcome | |
| *The risk in the intervention group (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; RCT: randomised controlled trial; RR: risk ratio. | ||||||
| GRADE Working Group grades of evidence. High certainty: we are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: we are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect. Very low certainty: we have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of effect. | ||||||
aDowngraded one level for for high risk of other source of bias.
bDowngraded one level for for high risk of publication bias.
cDowngraded one level for imprecision due to small sample size.
dDowngraded one level for imprecision due to small sample size; CIs are consistent with appreciable benefit and appreciable harm.