Study Stopped
Program Discontinued
Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD
RELIGHT
A Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as an Adjunctive Treatment for Major Depressive Disorder (RELIGHT)
1 other identifier
interventional
27
1 country
36
Brief Summary
A Phase 3, randomized, double-blind, placebo-controlled, multicenter trial of REL-1017 in patients with major depressive disorder (MDD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 major-depressive-disorder
Started Aug 2023
36 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
Study Start
First participant enrolled
August 17, 2023
CompletedFirst Submitted
Initial submission to the registry
August 21, 2023
CompletedFirst Posted
Study publicly available on registry
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2024
CompletedNovember 6, 2025
January 1, 2025
1.3 years
August 21, 2023
November 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
REL-1017 25 mg
EXPERIMENTALDuring 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)
Placebo
PLACEBO COMPARATORDuring the double blind treatment period (28 days), participants will take 1 tablet of placebo, orally, per day in addition to their ongoing antidepressant (ADT)
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index (BMI) between 18.0 and 35.0 kg/m2.
- Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD.
- Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Levomecor Inc.lead
Study Sites (36)
Relmada Site
Dothan, Alabama, 36303, United States
Relmada Site
Homewood, Alabama, 35209, United States
Relmada Site
Anaheim, California, 92805, United States
Relmada Site
Lafayette, California, 94549, United States
Relmada Site
Newport Beach, California, 92660, United States
Relmada Site
Orange, California, 92868, United States
Relmada Site
Redlands, California, 92374, United States
Relmada Site
Sherman Oaks, California, 91403, United States
Relmada Site
Farmington, Connecticut, 06030, United States
Relmada Site
Brandon, Florida, 33511, United States
Relmada Site
Hialeah, Florida, 33027, United States
Relmada Site
Jacksonville, Florida, 32256, United States
Relmada Site
Miami, Florida, 33133, United States
Relmada Site
Miami, Florida, 33174, United States
Relmada Site
Okeechobee, Florida, 34972, United States
Relmada Site
Tampa, Florida, 33607, United States
Relmada Site
Springfield, Illinois, 62794, United States
Relmada Site
Baltimore, Maryland, 21208, United States
Relmada Site
Mankato, Minnesota, 56001, United States
Relmada Site
Toms River, New Jersey, 08755, United States
Relmada Site
Brooklyn, New York, 11235, United States
Relmada Site
Cedarhurst, New York, 11516, United States
Relmada Site
New York, New York, 10036, United States
Relmada Site
Philadelphia, Pennsylvania, 19104, United States
Relmada Site
Franklin, Tennessee, 37067, United States
Relmada Site
Memphis, Tennessee, 38119, United States
Relmada Site
Austin, Texas, 78712, United States
Relmada Site
Bellaire, Texas, 77401, United States
Relmada Site
Friendswood, Texas, 77546, United States
Relmada Site
Houston, Texas, 77030, United States
Relmada Site
Wichita Falls, Texas, 76309, United States
Relmada Site
Clinton, Utah, 84015, United States
Relmada Site
Draper, Utah, 84020, United States
Relmada Site
Rutland, Vermont, 05701, United States
Relmada Site
Charlottesville, Virginia, 22903, United States
Relmada Site
Seattle, Washington, 98104, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Paul Greene, PhD
Relmada Therapeutics
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
August 21, 2023
First Posted
August 25, 2023
Study Start
August 17, 2023
Primary Completion
December 19, 2024
Study Completion
December 19, 2024
Last Updated
November 6, 2025
Record last verified: 2025-01