A Phase 3, Multicenter, Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder (RELIANCE-OLS)
Open-Label Study to Assess the Long-Term Safety of REL-1017 as a Treatment of Major Depressive Disorder
Sponsor: Relmada Therapeutics, Inc.
Enrolling: Male and Female Patients
Study Length: 13 Months
Clinic Visits: 8
IRB Number: 8253
U.S. Govt. ID: NCT04855760
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. This is a one-year open-label study to evaluate the long-term safety and tolerability of an investigational drug called REL-1017 (esmethadone) when taken alone (monotherapy) or when taken with other antidepressants (adjunctive therapy). Study visits will include physical examination, vital signs, electrocardiograms, blood collection, urine collection, and psychological assessments. Participants may be enrolled in the study for up to 13 months, consisting of 12 months of treatment and a 1-month post-treatment follow-up visit. Telephone contact will be made throughout the study.
Investigator
David Hellerstein, MD
Do You Qualify?
Are you currently depressed? Yes No
Are you between the ages of 18-65? Yes No
Is your body mass index (BMI) between 30.1 - 35.0? Yes No
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For more information, please contact:
Genevieve Falabella
genevieve.falabella@nyspi.columbia.edu
646-774-8004