Assessing Symptomatic Clinical Episodes in Depression

NCT03595579 ↗

Phase 2 Completed 97 enrolled Axsome Therapeutics, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomized, Double-Blind, Active-Controlled Study of AXS-05 for MDD.

Timeline

Start: 2018-05-30
Primary completion: 2019-01-07
Completion: 2019-01-07

Outcome

Met primary endpoint

paper The mean change from baseline in MADRS score over weeks 1-6 (overall treatment effect) was significantly greater with dextromethorphan-bupropion than with bupropion PMID 35582785 ↗

registry analysis (superiority test); AXS-05 vs Bupropion; p <.001; Mixed Models Analysis NCT03595579 ↗

Publications

Tabuteau H, Jones A, Anderson A, Jacobson M, Iosifescu DV. Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial. Am J Psychiatry. 2022 Jul;179(7):490-499. doi: 10.1176/appi.ajp.21080800. Epub 2022 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Bupropion	Small molecule	105 mg	—
Subject	Dextromethorphan	Unknown	45 mg	Oral