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)
Overview
- Phase
- Phase 3
- Intervention
- REL-1017
- Conditions
- Major Depressive Disorder
- Sponsor
- Levomecor Inc.
- Enrollment
- 236
- Locations
- 1
- Primary Endpoint
- Change in the MADRS10 total score
- Status
- Terminated
- Last Updated
- 5 months ago
Overview
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 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Body mass index (BMI) between 18.0 and 35.0 kg/m
- •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 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.
- •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.
Arms & Interventions
REL-1017 25 mg
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)
Intervention: REL-1017
Placebo
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).
Intervention: Placebo
Outcomes
Primary Outcomes
Change in the MADRS10 total score
Time Frame: Day 28
Therapeutic efficacy of REL-1017 as adjunctive treatment 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. A negative change from baseline indicates improvement.
Secondary Outcomes
- Change in CGI-S score(Day 28)
- Change in the MADRS10 total score(Day 7)
- MADRS10 Response Rater(Day 28)
- MADRS10 Remission Rate(Day 28)