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. 2021 Dec 7;2021(12):CD004044. doi: 10.1002/14651858.CD004044.pub5

Summary of findings 7. Antidepressant plus antipsychotic compared to placebo plus antidepressant for psychotic depression.

Antidepressant plus antipsychotic compared to placebo plus antidepressant for psychotic depression
Patient or population: adults with psychotic depression
Setting: hospital
Intervention: antidepressant plus antipsychotic
Comparison: placebo plus antidepressant
Outcomes Anticipated absolute effects* (95% CI) Relative effect
(95% CI) №. of participants
(studies) Certainty of evidence
(GRADE) Comments
Risk with placebo plus antidepressant Risk with antidepressant plus antipsychotic
Clinical response of depression Study population RR 1.42
(1.11 to 1.80) 245
(4 RCTs) ⊕⊕⊝⊝
Very lowa,b,c One study defined response as HRSD‐17 < 7, another study defined response as HAMD‐17 ≦ 10, another study defined response as HAMD‐17 < 11, and a fourth study defined response as reduction in HRSD‐17 > 50%
436 per 1000 619 per 1000
(484 to 784)
Overall dropouts Study population RR 0.91
(0.55 to 1.50) 245
(4 RCTs) ⊕⊝⊝⊝
Very lowa,b,d  
207 per 1,000 189 per 1,000
(114 to 311)
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; HAMD: Hamilton Depression Rating Scale; HRSD: Hamilton Rating Scale for Depression; 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 for high risk of attrition bias and other source of bias in one study.

bDowngraded one level 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.