A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- Controlled Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder (The RELIANCE-II Study)

REL-1017-302

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. Study participants will continue to take their current antidepressant therapy in addition to the study drug or placebo for the duration of the treatment period.

2021-03-30

2024-06-01

2024-06-01

Recruiting

Early phase I

300

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. * Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with an antidepressant medication 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. * Any lifetime experience of having received ketamine or esketamine as a treatment for MDD, or as part of a clinical trial.

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2024-02-16