A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Completed · Phase 3

Conditions studied: Treatment Resistant Major Depressive Disorder

In brief

To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD). This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD. Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.

Key facts

Study ID

NCT02741791

Run by

Axsome Therapeutics, Inc.

People needed

312

Starts

2016-03-01

Expected to finish

2020-03-20

Last updated by the study team

2021-03-24

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Anaheim, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Garden Grove, California, United States
• Study site — Oakland, California, United States
• Study site — Oceanside, California, United States
• Study site — Panorama City, California, United States
• Study site — Redlands, California, United States
• Study site — Riverside, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Sherman Oaks, California, United States
• Study site — Temecula, California, United States
• Study site — Upland, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Cromwell, Connecticut, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Coral Springs, Florida, United States
• Study site — Fort Lauderdale, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Jacksonville, Florida, United States
• Study site — Lakeland, Florida, United States
• Study site — North Miami, Florida, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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