The purpose of this clinical research study is to understand how effective and safe an investigational study drug called lumateperone is and whether it works to reduce the severity of depressive symptoms in adults with Major Depressive Disorder (MDD) and early life trauma. The main questions it aims to answer are:
Aim 1: To assess the efficacy of lumateperone 42 mg administered once daily compared with placebo in the treatment of patients with Major Depressive Disorder and early life abuse.
Aim 2: To assess neurocircuitry encoding of threat and reward learning as predictors of lumateperone response and as mechanisms of treatment action, and assess the change from pre-dose to post-dose of task-evoked brain activation.
Provide written informed consent before the initiation of any study-specific procedures.
Male or female, between the ages of 21 and 70 years, inclusive;
Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, Text Revision (DSM-5-TR) criteria for Major Depressive Disorder (MDD) without psychotic symptoms, as confirmed by a trained rater using the modified Structured Clinical Interview (DIAMOND) for DSM-5,
MADRS total score ≥ 22 at Screening (Visit 1) and Baseline (Visit 2)
Has a current primary DSM-5-TR psychiatric diagnosis other than Major depressive disorder. These include: PTSD, OCD, Bipolar Disorder, Schizophrenia, schizoaffective disorder, or other psychotic disorder. Intellectual disability, Dementia or other cognitive disorders. Moderate or severe substance use disorder (excluding for nicotine)
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or
Parallel
Lumateperone 42 mg
DrugLumateperone, 42 mg, will be orally taken by participants once daily for 6 weeks.
Placebo
Other interventionA matching placebo will be taken orally by participants once daily for 6 weeks.
The primary efficacy endpoint is the absolute change in Montgomery-Åsberg Depression Rating Scale (MADRS) total scores from Baseline to end of Treatment visit at Week 6 in subjects on ADT plus Lumateperone or matching placebo.
The MADRS is a 10-item questionnaire with each item scored between 0 and 6, resulting in a total score between 0 and 60, with scores above 34 indicating severe depression. Higher MADRS scores indicate more severe depression. The questionnaire is most frequently used in clinical studies to measure outcomes in antidepressant efficacy studies. This scale exhibits construct validity (internal homogeneity) and the concepts of endogenous and non-endogenous depression. The questionnaire includes questions on the following symptoms: (1) apparent sadness; (2) reported sadness; (3) inner tension; (4) reduced sleep; (5) reduced appetite; (6) concentration difficulties; (7) lassitude; (8) inability to feel; (9) pessimistic thoughts; (10) suicidal thoughts. The MADRS must be administered using the Structured Interview Guide for the MADRS (SIGMA). The MADRS total score at screening is a major inclusion criterion of the study, as well as the primary outcome measure for the study.
The key secondary efficacy endpoint is the change from baseline to end of Week 7 in the Clinical Global Impression of Severity (CGI-S) score.
The CGI-S measures the severity of the disease using a 7-point Likert scale ranging from 1=normal, not at all ill to 7=among the most extremely ill subjects
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