A Study to Assess the Efficacy and Safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD)
Reliance I
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)
1 other identifier
interventional
227
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 major-depressive-disorder
Started Jan 2021
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 7, 2020
CompletedFirst Posted
Study publicly available on registry
December 29, 2020
CompletedStudy Start
First participant enrolled
January 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2022
CompletedResults Posted
Study results publicly available
March 26, 2024
CompletedAugust 27, 2024
August 1, 2024
1.8 years
December 7, 2020
February 16, 2024
August 2, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the MADRS10 Total Score From Baseline to 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. 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 Outcomes (2)
MADRS10 Remission Rate (Total Score ≤10) at Day 28
Day 28
MADRS10 Response Rate (Improvement ≥50% Compared With Total Baseline Score) at Day 28
Day 28
Study Arms (2)
REL-1017
EXPERIMENTALA 75 mg REL-1017 loading dose (three 25 mg REL-1017 tablets) will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 25 mg REL-1017 in addition to their ongoing antidepressant.
Placebo
PLACEBO COMPARATORThree tablets of matching placebo will be administered on Day-1 of the 28-day treatment period. From Day-2 to Day-28, participants will take 1 placebo tablet in addition to their ongoing antidepressant.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Relmada Site
Miami, Florida, 33175, United States
Relmada Site
Miami Springs, Florida, 33166, United States
Relmada Site
Palm Bay, Florida, 32905, United States
Relmada Site
Decatur, Georgia, 30030, United States
Relmada Site
Chicago, Illinois, 60634, United States
Relmada Site
Boston, Massachusetts, 02116, United States
Relmada Site
Watertown, Massachusetts, 02472, United States
Relmada Site
O'Fallon, Missouri, 63368, United States
Relmada Site
New York, New York, 10128, United States
Relmada Site
Cincinnati, Ohio, 45215, United States
Relmada Site
Austin, Texas, 78737, United States
Related Publications (1)
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.
PMID: 38917366RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Marco Pappagallo, MD
- Organization
- Relmada Therapeutics
Study Officials
- STUDY DIRECTOR
Marco Pappagallo, MD
Relmada Therapeutics
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Expanded Access
- Yes
Study Record Dates
First Submitted
December 7, 2020
First Posted
December 29, 2020
Study Start
January 8, 2021
Primary Completion
November 1, 2022
Study Completion
November 10, 2022
Last Updated
August 27, 2024
Results First Posted
March 26, 2024
Record last verified: 2024-08