A Double-blind, Placebo-controlled Study of Antidepressant Augmentation With Agomelatine

Summary

The purpose of this study was to investigate the efficacy and safety of antidepressant augmentation with agomelatine in the treatment of patients with depression who did not demonstrate satisfying response to selective serotonin reuptake inhibitor (SSRI) and serotonin-noradrenaline reuptake inhibitor (SNRI) during their early phase of treatment; this study also aims to explore the effects of augmenting antidepressant treatment with agomelatine on various aspects, including sleep quality, quality of life, social functioning, and cognitive function in patients with MDD.

Timeline

Start

2020-10-01

Primary completion

2022-12-30

Completion

2023-01-30

Outcome

Missed primary endpoint

paper The between-group difference in HAMD-17 score reduction from baseline to week 8 was not significant (difference = - 0.12, 95% CI = - 3.94 to 3.70, P = 0.90 PMID 40038707 ↗

Publications

• Ju Y, Ou W, Chen H, Yang L, Long Y, Liang H, Xi Z, Huang M, Chen W, Lv G, Shao F, Liu B, Liu J, Li Z, Liao M, Liang W, Yao Z, Zhang Y, Li L. Agomelatine as adjunctive therapy with SSRIs or SNRIs for major depressive disorder: a multicentre, double-blind, randomized, placebo-controlled trial. BMC Med. 2025 Mar 5;23(1):137. doi: 10.1186/s12916-025-03951-0.

Drugs

Indications