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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)
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.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Relmada Site
Miami, Florida, United States
Relmada Site
Miami Springs, Florida, United States
Relmada Site
Palm Bay, Florida, United States
Relmada Site
Decatur, Georgia, United States
Relmada Site
Chicago, Illinois, United States
Relmada Site
Boston, Massachusetts, United States
Relmada Site
Watertown, Massachusetts, United States
Relmada Site
O'Fallon, Missouri, United States
Relmada Site
New York, New York, United States
Relmada Site
Cincinnati, Ohio, United States
Start Date
January 8, 2021
Primary Completion Date
November 1, 2022
Completion Date
November 10, 2022
Last Updated
August 27, 2024
227
ACTUAL participants
REL-1017
DRUG
Placebo
DRUG
Lead Sponsor
Relmada Therapeutics, Inc.
NCT07115329
NCT06793397
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07025720