Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse

Part of paid clinical trials in Austin, Texas.

Sponsor
University of Texas at Austin
Study ID
NCT07369115
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Early Life Trauma
  • Major Depressive Diorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Lumateperone 42 mg — DRUG
    Lumateperone, 42 mg, will be orally taken by participants once daily for 6 weeks.
  • Placebo — OTHER
    A matching placebo will be taken orally by participants once daily for 6 weeks.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active Drug Arm - Lumateperone
    Lumateperone, 42 mg, for 6 weeks to be taken orally once daily for 25 participants
  • Placebo Comparator: Inactive Drug Arm - Placebo
    25 Participants will receive a matching placebo capsule for 6 weeks to be taken orally once daily.

Primary Outcome Measure

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. [ Time Frame: Change from Baseline MADRS score at enrollment to end of study (week 7) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Health Discovery BuildingAustinTexas78701
Jesus A Gonzalez
[email protected]
(512) 495-5136

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By research site
Health Discovery Building· Austin, TX

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