Intra-Cellular Therapies, Inc. / "A Randomized, Double-blind, Placebo-controlled, Single Site Study to Evaluate the Efficacy of Lumateperone for the Treatment of Major Depressive Disorder (MDD) and Early Life Trauma in Adult Patients Aged 21 to 70 Years
University of Texas at Austin
Summary
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.
Eligibility
- Age range
- 21–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Provide written informed consent before the initiation of any study-specific procedures. NOTE: Patients who are unable to independently provide informed consent will be ineligible to participate in this study. 2. Male or female, between the ages of 21 and 70 years, inclusive; 3. 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, 4. MADRS total…
Interventions
- DrugLumateperone 42 mg
Lumateperone, 42 mg, will be orally taken by participants once daily for 6 weeks.
- OtherPlacebo
A matching placebo will be taken orally by participants once daily for 6 weeks.
Location
- Health Discovery BuildingAustin, Texas