Randomized, Double-Blind, Placebo-Controlled Trial of REL-1017 as Adjunctive Treatment for MDD (RELIGHT)
Major Depressive Disorder, Depression
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring REL-1017, esmethadone, Relmada, antidepressant, adjunctive, NMDA receptor antagonist, Relight, Depression
Eligibility Criteria
Inclusion Criteria: Male or female outpatients, 18-65 years of age, inclusive. Currently meets DSM-5 criteria for MDD without psychotic features, based on the SCID-5-CT, with a current major depressive episode (MDE). Inadequate response to 1 to 3 adequate antidepressant treatments in the current MDE. Exclusion Criteria: 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. Breast-feeding or planning to breast-feed.
Sites / Locations
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
- Relmada SiteRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
REL-1017 25 mg
Placebo
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)
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)