Status:
COMPLETED
Safety of REL-1017 for Major Depressive Disorder
Lead Sponsor:
Relmada Therapeutics, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This was a 1-year, multicenter, open-label, long-term study to assess the safety of REL-1017 once daily (QD) as monotherapy or as adjunctive treatment of Major Depressive Disorder. Adjunctive study pa...
Detailed Description
This was a multicenter, open-label, long-term study of REL-1017 to evaluate the long-term safety and long-term durability of response in patients with MDD. Patients who completed previous randomized, ...
Eligibility Criteria
Inclusion
- Adults 18 to 65 years, inclusive.
- Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- Current major depressive episode.
Exclusion
- Any current and primary psychiatric disorder other than Major Depressive Disorder.
- History of bipolar I and II disorder, psychosis, and/or mania.
- Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study.
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2023
Estimated Enrollment :
627 Patients enrolled
Trial Details
Trial ID
NCT04855760
Start Date
April 1 2021
End Date
July 27 2023
Last Update
February 11 2025
Active Locations (9)
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1
Relmada Site
Miami, Florida, United States, 33015
2
Relmada Site
Miami, Florida, United States, 33175
3
Relmada Site
Orlando, Florida, United States, 32801
4
Relmada Site
Palm Bay, Florida, United States, 32905