Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI).
Journal of Clinical Psychiatry May 30, 2022 D. Iosifescu, A. Jones, C. O'gorman et al.
In a six-week phase 3 trial, the combination drug dextromethorphan-bupropion (AXS-05) reduced depressive symptoms more than placebo in adults with major depressive disorder. Those taking the drug showed an average 15.9-point drop on the Montgomery-Asberg Depression Rating Scale versus a 12.0-point drop with placebo, a statistically significant difference. Benefits appeared as early as one week. At six weeks, 39.5% of the drug group achieved remission compared to 17.3% of the placebo group, and 54.0% had a clinical response versus 34.0%. Common side effects included dizziness, nausea, and headache. The drug was not linked to weight gain or sexual dysfunction.