Relmada Therapeutics, Inc is recruiting patients for the clinical trial to assess the efficacy and safety of REL-1017 as Adjunctive Treatment for Major Depressive Disorder (MDD) (RELIANCE-II).
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.
The researchers plan that March 30, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in June 2022.
Among primary outcome measures are the Change in the MADRS10 total score and Therapeutic efficacy of REL-1017 as adjunctive treatment versus placebo in the Montgomery-Asberg Depression Rating Scale (MADRS10).
The study will take place at the Relmada Site 213, Hallandale Beach, Florida, United States; Relmada Site 218, Miami, Florida, United States; Relmada Site 207, Savannah, Georgia, United States; Relmada Site 212, Oklahoma City, Oklahoma, United States.
Adults 18 to 65 years, inclusive. - Diagnosed with Major Depressive Disorder (MDD) based on Structured Clinical Interview for DSM-5 (SCID-5) for MDD. - Current major depressive episode. - Treated on approved, stable first-line anti-depressant therapy with inadequate response to 1 to 3 valid courses of treatment with an antidepressant medication Exclusion Criteria: - Any current and primary psychiatric disorder other than Major Depressive Disorder. - Severe alcohol or substance use disorder. - History of bipolar I and II disorder, psychosis, and/or mania. - Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study. - Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time can be enrolled into this research.
There are a number of conditions that do not allow participation, such as:
- Any current and primary psychiatric disorder other than Major Depressive Disorder. - Severe alcohol or substance use disorder. - History of bipolar I and II disorder, psychosis, and/or mania. - Acute or chronic condition that, in the Investigator's opinion, would limit the subject's ability to complete or participate in this clinical study. - Prior participation in a ketamine, esketamine, dextromethorphan or any other NMDAR- antagonist study, or received esketamine at any time.
The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04855747
