Status:
TERMINATED
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
Lead Sponsor:
Levomecor Inc.
Conditions:
Major Depressive Disorder
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Detailed Description
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
- Body mass index (BMI) between 18.0 and 35.0 kg/m2.
- Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
Exclusion
- Psychiatric hospitalization during the current major depressive episode.
- History or presence of clinically significant health conditions which in the opinion of the Investigator would negatively impact the safety of the participant.
- Participants who, in the Investigator's judgment, are at significant risk for suicide.
- Pregnant or planning to become pregnant.
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 19 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06011577
Start Date
August 17 2023
End Date
December 19 2024
Last Update
November 6 2025
Active Locations (36)
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1
Relmada Site
Dothan, Alabama, United States, 36303
2
Relmada Site
Homewood, Alabama, United States, 35209
3
Relmada Site
Anaheim, California, United States, 92805
4
Relmada Site
Lafayette, California, United States, 94549