A Study to Assess the Efficacy and Safety of REL-1017 as Monotherapy for Major Depressive Disorder (MDD)

Study Overview
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Brief Summary
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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 a monotherapy for Major Depressive Disorder.

Official Title
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A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of REL-1017 Monotherapy for Major Depressive Disorder

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: REL-1017
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: REL-1017 25 mg<br>During the double blind treatment period (28 days), participants will take 1 tablet of REL-1017 25 mg, orally, per day | Drug: REL-1017<br>* REL-1017 tablet<br>|
| Placebo Comparator: Placebo<br>During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day | Drug: Placebo<br>* Placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the MADRS10 total score | Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement. | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CGI-S score | Therapeutic efficacy of REL-1017 as an monotherapy versus placebo in Clinical Global Impression of Severity (CGI-S) The CGI-S is a standard method used in clinical studies to quantify and track patient progress and treatment response over time. The scale is composed of 7 ratings: 1 = normal, not at all ill; 2 = borderline ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill patients. The score ranges from 1 to 7, and a lower CGI-S score indicates lower levels of depression. | Day 28 | 
| Change in the MADRS10 total score | Therapeutic efficacy of REL-1017 as monotherapy versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10) A higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60 with scores above 34 indicating severe depression. A negative change from baseline indicates improvement. | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REL-1017