Original Research J Clin Psychiatry May 2022

Efficacy and Safety of AXS-05 (Dextromethorphan-Bupropion) in Patients With Major Depressive Disorder: A Phase 3 Randomized Clinical Trial (GEMINI)

JCP 2022;83(4):10.4088/JCP.21m14345

Full Article Read the complete peer-reviewed article in J Clin Psychiatry. JCP 2022;83(4):10.4088/JCP.21m14345 Clinical Summary Many patients with major depressive disorder need symptom relief sooner than standard oral antidepressants typically provide, and first-line remission rates remain limited. This trial addresses whether an oral, non-monoaminergic option can deliver clinically meaningful improvement within the first 1–2 weeks while remaining tolerable over acute treatment. FAQ What did the GEMINI trial find about AXS-05 for major depressive disorder? 10 questions
Key Takeaways In this 6-week trial, patients started dextromethorphan-bupropion 45 mg-105 mg once daily for 3 days and then twice daily thereafter, with a significant advantage over placebo on the primary endpoint by week 6 (least-squares mean difference, −3.87; 95% confidence interval [CI], −1.39 to −6.36; P = .002). 6 takeaways Clinical Guide How should clinicians identify appropriate adults with major depressive disorder for dextromethorphan-bupropion and monitor early response and tolerability over the first 6 weeks? 8 steps
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