Status:
COMPLETED
Open-Label Safety Study of AXS-05 in Subjects With Depression
Lead Sponsor:
Axsome Therapeutics, Inc.
Conditions:
Major Depressive Disorder
Treatment Resistant Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
An open-label, long-term, safety study of AXS-05 in patients with major depressive disorder (MDD), including treatment resistant depression.
Detailed Description
A multi-center, open-label, long-term study to evaluate the safety and efficacy of AXS-05 in patients with major depressive disorder, including treatment resistant depression, treated for up to one ye...
Eligibility Criteria
Inclusion
- Diagnosis of major depressive disorder, including treatment resistant depression
- Body mass index (BMI) between 18 and 40 kg/m\^2, inclusive
- Agree to use adequate method of contraception for the duration of the study
- Additional criteria may apply
Exclusion
- Suicide risk
- Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
- Additional criteria may apply
Key Trial Info
Start Date :
July 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2020
Estimated Enrollment :
876 Patients enrolled
Trial Details
Trial ID
NCT04039022
Start Date
July 8 2019
End Date
October 23 2020
Last Update
October 12 2022
Active Locations (51)
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1
Clinical Research Site
Phoenix, Arizona, United States, 85012
2
Clinical Research Site
Little Rock, Arkansas, United States, 72209
3
Clinical Research Site
Bellflower, California, United States, 90706
4
Clinical Research Site
Beverly Hills, California, United States, 90210