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.
IRB approval #: 20210876
This study is being conducted only in the United States at various locations. Site Locations are listed on Clinicaltrials.gov
• Adults 18 to 65 years, inclusive.
• Meets DSM-5 criteria for major depressive disorder.
• Currently experiencing a major depressive episode.
• Has had an inadequate response to current ongoing treatment with an approved antidepressant.
- Treatment-resistant depression.
- History of bipolar I or II disorder.
- Any psychiatric condition which takes a primary focus of treatment over MDD.
- Significant or poorly controlled concomitant medical illness.
- Alcohol or other substance use disorder.
- Pregnant, breast-feeding or planning to become pregnant or breast-feed during the study.
- Significant risk of suicide.
