Serotonin dopamine activity modulators have been approved as an adjunctive treatment to antidepressants in patients with inadequate response. These drugs have been proposed to have a beneficial effect on cognition, sleep-related problems, and other affective symptoms in patients of depression. Previous studies have shown inconsistent evidence and have not reported a pooled effect of the two drugs of this class viz., aripiprazole and brexpiprazole. This meta-analysis evaluated the effect of augmentation with serotonin dopamine activity modulator (SDAM) drugs in patients with major depression. The meta-analysis protocol was made as per PRISMA-P guidelines and registered in PROSPERO. PubMed/MEDLINE, Cochrane Clinical Trial registry, EudraCT databases were searched with prespecified search terms. A random-effects meta-analysis was performed using the meta package in R software. Fifteen studies were included in this meta-analysis. The random effects model analysis observed a pooled effect of 1.55 [95% CI 1.32-1.84; prediction interval: 0.95-2.55, z = 5.19 (p < 0.0001)] for remission between the SDAM and placebo groups. A pooled effect of 1.58 [95% CI 1.37-1.83; prediction interval: 1.00-2.51, z = 6.34 (p<0.0001)] for adverse events and 0.72 [95% CI 0.48-1.08) prediction interval: 0.46-1.12] [z = -1.58 (p = 0.113)] for serious adverse events was observed. No significant publication bias was noticed. The quality of the evidence was rated as high. Adjunct SDAM increased remission in patients and had no significant effect on serious adverse events compared to placebo. Therefore, we conclude that SDAM drugs can be an effective and safe antidepressant augmentation strategy in MDD patients.

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