Clinical trial NCT04688164: A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Official title: 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-I Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: REL-1017
Lead sponsor: Relmada Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 227
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* Adults 18 to 65 years, inclusive.
* Diagnosed with Major Depressive Disorder (MDD) based on structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, DSM-5 (SCID-5) for MDD.
* Current major depressive episode.
* With inadequate response to 1-3 first-line antidepressants administered at an adequate and stable dose

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.

Primary outcomes:
measure: Change in the MADRS10 Total Score From Baseline to Day 28
timeFrame: Day 28
Secondary outcomes:
measure: MADRS10 Remission Rate (Total Score ≤10) at Day 28
timeFrame: Day 28
measure: MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28
timeFrame: Day 28
Other outcomes:
Locations:
city: Miami Springs
country: United States
facility: Relmada Site
state: Florida
city: Miami
country: United States
facility: Relmada Site
state: Florida
city: Palm Bay
country: United States
facility: Relmada Site
state: Florida
city: Decatur
country: United States
facility: Relmada Site
state: Georgia
city: Chicago
country: United States
facility: Relmada Site
state: Illinois
city: Boston
country: United States
facility: Relmada Site
state: Massachusetts
city: Watertown
country: United States
facility: Relmada Site
state: Massachusetts
city: O'Fallon
country: United States
facility: Relmada Site
state: Missouri
city: New York
country: United States
facility: Relmada Site
state: New York
city: Cincinnati
country: United States
facility: Relmada Site
state: Ohio
city: Austin
country: United States
facility: Relmada Site
state: Texas
Study officials:
affiliation: Relmada Therapeutics
name: Marco Pappagallo, MD
role: STUDY_DIRECTOR
References:
citation: Fava M, Stahl SM, Pani L, De Martin S, Cutler AJ, Maletic V, Gorodetzky CW, Vocci FJ, Sapienza FL, Kosten TR, Kroger C, Champasa P, O'Gorman C, Guidetti C, Alimonti A, Comai S, Mattarei A, Folli F, Bushnell D, Traversa S, Inturrisi CE, Manfredi PL, Pappagallo M. Efficacy and Safety of Esmethadone (REL-1017) in Patients With Major Depressive Disorder and Inadequate Response to Standard Antidepressants: A Phase 3 Randomized Controlled Trial. J Clin Psychiatry. 2024 Jun 17;85(3):24m15265. doi: 10.4088/JCP.24m15265.