Efficacy of antidepressants in addition to psychotherapy in major depressive disorder: a systematic review and meta-analysis of randomized clinical trials

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BACKGROUND: Major depressive disorder (MDD) impairs daily functioning and is often treated with psychotherapy, antidepressants (AD), or both. While combined therapy is recommended, its efficacy remains unclear. This systematic review and meta-analysis aimed to evaluate the efficacy of adding an AD to psychotherapy, compared with psychotherapy plus a placebo. METHODS: A systematic search was conducted across PubMed, Embase, and Cochrane Central for randomized controlled trials. Studies were included if they compared AD in addition to psychotherapy versus psychotherapy plus a placebo, with depression severity assessed using standardized scales. Meta-analyses were performed on depression severity outcomes, using change-from-baseline scores and endpoint scores. OUTCOMES: Eleven trials were included, involving various AD and psychotherapies. The pooled effect size for change-from-baseline scores across trials showed a nonsignificant result SMD = 0.31; CI 95% (-0.07; 0.70) (p-value = 0.1). Meta-analyses based on endpoint depression scores were non-significant, and the observed effect sizes may fall below the threshold for clinical significance. The quality of evidence was rated as very low according to the GRADE assessment. CONCLUSION: Current evidence does not indicate the benefit of adding antidepressants to psychotherapy for MDD. Evidence quality is very low, with few trials, methodological limitations, intervention heterogeneity, and selected populations limiting interpretability and generalizability. Larger, high-quality RCTs in broader populations are needed and should systematically include psychotherapy alongside antidepressants.

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