Status:
COMPLETED
A Trial of AXS-05 in Patients With Major Depressive Disorder
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
Depression
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of AXS-05 in patients with major depressive disorder (MDD).
Detailed Description
This study will evaluate AXS-05 in a randomized, double-blind, placebo-controlled study in patients with MDD. Eligible patients will be randomized in a 1:1 ratio to treatment with AXS-05 or placebo fo...
Eligibility Criteria
Inclusion
- Key
- Age 18 - 65
- Currently meets DSM-5 criteria for MDD
- Body Mass Index between 18 and 40 kg/m\^2, inclusive
- Key
Exclusion
- Suicide risk
- History of treatment resistance in current depressive episode
- History of electroconvulsive therapy, vagus nerve stimulation, transcranial magnetic stimulation or any experimental central nervous system treatment during the current episode or in the past 6 months
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
327 Patients enrolled
Trial Details
Trial ID
NCT04019704
Start Date
June 20 2019
End Date
December 5 2019
Last Update
October 12 2022
Active Locations (43)
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1
Clinical Research Site
Phoenix, Arizona, United States, 85012
2
Clinical Research Site
Phoenix, Arizona, United States, 85016
3
Clinical Research Site
Little Rock, Arkansas, United States, 72209
4
Clinical Research Site
Bellflower, California, United States, 90706