This is a multicenter, randomized, double-blind, placebo-controlled parallel-group, fixed-dose study in patients with a primary diagnosis of MDD according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) who have an inadequate response to ongoing ADT.
Male or female patients between the ages of 18 and 65 years, inclusive;
The start of the current major depressive episode (MDE) is at least 12 weeks but not more than 18 months prior to Screening;
Has at least moderate severity of illness based on rater-administered MADRS total score ≥ 24 at Screening and at Baseline;
Has at least moderate severity of illness based on CGI-S score ≥ 4 at Screening and at Baseline;
Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder or other psychotic disorder;
Bipolar Disorder;
Anxiety disorders such as Panic Disorder or Generalized Anxiety Disorder; Obsessive-compulsive Disorder; Posttraumatic Stress Disorder as primary diagnoses. Note: Anxiety symptoms may be allowed if secondary to MDD, provided these symptoms do not require concurrent treatment;
Eating disorder;
Parallel
Lumateperone
DrugLumateperone 42 mg capsules administered orally, once daily
Placebo
DrugMatching capsules administered orally, once daily
Montgomery-Asberg Depression Rating Scale
The MADRS is a clinician-rated 10 item scale to assess depressive symptoms. Each item is rated on a 7-point scale from 0-6. The total score ranges from 0 to 60 with a higher score indicating increased severity of depressive symptoms.
Clinical Global Impression Scale-Severity
The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
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