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-II Study)
Efficacy and Safety of REL-1017 as Adjunctive Treatment of Major Depressive Disorder
Sponsor: Relmada Therapeutics, Inc.
Enrolling: Male and Female Patients
Study Length: 58 Days
Clinic Visits: 8
IRB Number: 8240
U.S. Govt. ID: NCT04855747
Contact: Genevieve Falabella: 646-774-8004 / genevieve.falabella@nyspi.columbia.edu
Additional Study Information: We are currently enrolling individuals with Major Depressive Disorder (MDD) to participate in this research study. The main goals of this study are to assess the safety and efficacy of an investigational drug called REL-1017 as an adjunctive treatment for MDD. The study includes a 30-day screening period and a 28-day treatment period for a total of 58 days. Eligible participants will be randomly assigned to receive either REL-1017 (esmethadone) or a placebo (a pill without active study drug). Participants will also continue taking their regularly prescribed antidepressant medication. Study visits will include physical examination, vital signs, electrocardiograms, blood collection, urine collection, and assessments. Participants will be compensated for their time and reimbursed for travel expenses to and from the clinic.
This study is closed
Investigator
David Hellerstein, MD
Do You Qualify?
Are you currently depressed? Yes No
Are you between the ages of 18-65? Yes No
Are you currently prescribed an antidepressant medication? Yes No
Can your schedule accommodate frequent visits to the study center? Yes No
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For more information, please contact:
Genevieve Falabella
genevieve.falabella@nyspi.columbia.edu
646-774-8004