Status:
COMPLETED
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Lead Sponsor:
Relmada Therapeutics, Inc.
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is an outpatient, 2-arm, Phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of REL-1017 once daily (QD) as an adjunctive treatment of Major...
Eligibility Criteria
Inclusion
- Adults 18 to 65 years, inclusive.
- Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
- Current major depressive episode.
- With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose
Exclusion
- Any current and primary psychiatric disorder other than Major Depressive Disorder.
- Severe alcohol or substance use 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.
- Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
Key Trial Info
Start Date :
January 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2022
Estimated Enrollment :
227 Patients enrolled
Trial Details
Trial ID
NCT04688164
Start Date
January 8 2021
End Date
November 10 2022
Last Update
August 27 2024
Active Locations (11)
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1
Relmada Site
Miami, Florida, United States, 33175
2
Relmada Site
Miami Springs, Florida, United States, 33166
3
Relmada Site
Palm Bay, Florida, United States, 32905
4
Relmada Site
Decatur, Georgia, United States, 30030