~49 spots leftby Mar 2026

A Trial of AXS-05 in Patients With Major Depressive Disorder (GEMINI Trial)

Recruiting in Palo Alto (17 mi)
+41 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Axsome Therapeutics, Inc.
Pivotal Trial (Near Approval)
Prior Safety Data

Trial Summary

What is the purpose of this trial?A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).

Eligibility Criteria

Participant Groups

2Treatment groups
Experimental Treatment
Placebo Group
Group I: AXS-05Experimental Treatment1 Intervention
AXS-05 (bupropion and dextromethorphan) oral tablets
Group II: PlaceboPlacebo Group1 Intervention
Placebo oral tablets to match AXS-05
AXS-05 is already approved in United States for the following indications:
🇺🇸 Approved in United States as Auvelity for:
  • Major depressive disorder

Find A Clinic Near You

Research locations nearbySelect from list below to view details:
Clinical Research SiteGarden Grove, CA
Clinical Research SitePhiladelphia, PA
Clinical Research SiteHickory, NC
Clinical Research SiteNorth Miami, FL
More Trial Locations
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Who is running the clinical trial?

Axsome Therapeutics, Inc.Lead Sponsor

References