Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD

Study Overview
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Brief Summary
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A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).

Detailed Description
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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 an adjunctive treatment of Major Depressive Disorder in patients with inadequate response to ongoing background antidepressant treatment. Eligible patients will continue to take their background antidepressant therapy and be randomized in a 1:1 ratio to treatment with REL-1017 or placebo for a 4 week treatment period.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)

Conditions
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Major Depressive Disorder, Depression

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: Male or female outpatients, 18-65 years of age, inclusive. Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE). Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE. Exclusion Criteria: 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. Breast-feeding or planning to breast-feed.

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 in addition to their ongoing antidepressant (ADT) | Drug: REL-1017<br>* REL-1017 tablet<br>* Other names: esmethadone;|
| Placebo Comparator: Placebo<br>During the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT) | 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 MADRS Total Score From Baseline to Day 28 | The MADRS is a 10-item scale and items are scored between 0-6 points. For each item, a score of 0 indicates the absence of symptoms, and a score of 6 indicates symptoms of maximum severity. A maximum total score is 60 points. | Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, Depression