drugset / Trial / NCT04019704
A Trial of AXS-05 in Patients With Major Depressive Disorder
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Timeline
- Start
- 2019-06-20
- Primary completion
- 2019-11-26
- Completion
- 2019-12-05
Outcome
Met primary endpoint
registry analysis (superiority test); AXS-05 vs Placebo; p = 0.002; Mixed Models Analysis NCT04019704 ↗
paper The least-squares mean change from baseline to week 6 in MADRS total score was -15.9 points in the dextromethorphan-bupropion group and -12.0 points in the placebo group PMID 35649167 ↗
paper least-squares mean difference, -3.87; 95% confidence interval [CI], -1.39 to -6.36; P = .002 PMID 35649167 ↗
Publications
- Iosifescu DV, Jones A, O'Gorman C, Streicher C, Feliz S, Fava M, Tabuteau H. Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI). J Clin Psychiatry. 2022 May 30;83(4):21m14345. doi: 10.4088/JCP.21m14345.
- Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9(9):CD011612. doi: 10.1002/14651858.CD011612.pub3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bupropion | Small molecule | 105 mg | Oral |
| Subject | Dextromethorphan | Unknown | 45 mg | Oral |