Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive… (NCT07369115) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse
United States50 participantsStarted 2026-02
Plain-language 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.
Who can participate
Age range21 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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)
✓. Endorse \>=1 physical or sexual assault prior to age 16 on the interview-based trauma assessment.
✓. Participants must have been treated with the same dose of antidepressant therapy for at least 6 weeks, with less than 50% improvement, and be committed to stay on the same stable dosing regimen for the Screening period and for the entire study, at or above the minimally adequate dose in the ATRQ. Documentation of stable and ongoing ADT must be verified by documentation from the subject's psychiatrist, pharmacist, primary care physician, or other qualified healthcare professional.
✓. Females of childbearing potential agree to use at least an acceptable method of birth control (including but not limited to hormonal contraception, intrauterine device, vasectomized partner, bilateral tubal occlusion, condom with or without spermicide, cap with spermicide, diaphragm with spermicide, sponge with spermicide, or double barrier methods) from the time informed consent is provided through the end of the SFU period. NOTE: Females of non-childbearing potential (defined as either permanently sterilized, or post-menopausal females \[defined as at least one year with no menses without an alternative medical explanation\]) are exempt from the birth control requirement.
What they're measuring
1
The primary efficacy endpoint is the absolute change in Montgomery-Ã…sberg 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.
Timeframe: Change from Baseline MADRS score at enrollment to end of study (week 7)
✓. Ability to follow study instructions and likely to complete all required visits.
Exclusion criteria
✕. 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
✕.Other drugs with known psychotropic properties or any non-psychotropic drugs with known or potentially significant central nervous system.