Alkermes, Inc.
The purpose of this study is to assess the efficacy, safety and tolerability of ALKS 7290 following oral administration in adult participants with Major Depressive Disorder.
Inclusion Criteria: * Meets the DSM-5 criteria for MDD, as confirmed by both MINI and an adequate clinical psychiatric evaluation. * Is otherwise healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, and cardiac monitoring. * Participants must be stable on permitted medication prior to screening. * An inadequate response to an adequate dosage of antidepressant therapy in the current depressive episode. * Symptoms of depression that are considered moderate to severe, based on assessments completed with the study team during both screeni…
Daily oral ALKS 7290 with antidepressant therapy
Daily oral placebo with antidepressant therapy
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