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H. Tabuteau

2 papers in the library · publishing 2022

Papers

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.

Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial.

American Journal of Psychiatry May 18, 2022 H. Tabuteau, A. Jones, Ashley Anderson et al.

In a randomized trial, the combination drug dextromethorphan-bupropion (AXS-05) improved depressive symptoms more than bupropion alone in adults with moderate-to-severe major depressive disorder. Over six weeks, the average reduction in depression scores was 13.7 points with the combination versus 8.8 points with bupropion. By week six, 46.5% of those taking the combination achieved remission, compared to 16.2% taking bupropion. The combination was generally well tolerated, with common side effects including dizziness, nausea, and dry mouth, and was not linked to weight gain or sexual dysfunction.