Status:
TERMINATED
A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Lead Sponsor:
Levomecor Inc.
Conditions:
Major Depressive Disorder
Depression
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
- 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.
- Current Major Depressive Episode (MDE).
- Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with a depressant medication in the current MDE.
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.
- Poorly controlled diabetes as defined by HbA1c \> 7.5%, despite standard care. Subjects with HbA1c \>7.5% may continue in the study if approved by the Relmada Medical Monitor.
- Having received ketamine or esketamine within 60 days prior to Screening.
Key Trial Info
Start Date :
March 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2025
Estimated Enrollment :
236 Patients enrolled
Trial Details
Trial ID
NCT04855747
Start Date
March 30 2021
End Date
January 14 2025
Last Update
November 6 2025
Active Locations (70)
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1
Relmada Site
Homewood, Alabama, United States, 35209
2
Relmada Site
Chandler, Arizona, United States, 85226
3
Relmada Site
Chandler, Arizona, United States, 85286
4
Relmada Site
Phoenix, Arizona, United States, 85016