Lumateperone for Depression and Childhood Trauma
(ITI-ELA-MDD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Adults aged 21-70 with Major Depressive Disorder and a history of physical or sexual assault before age 16. They must have been on the same antidepressant dose for at least 6 weeks with less than half improvement, agree to maintain this dose, and women must use birth control if able to bear children.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive lumateperone 42 mg or placebo once daily for 6 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lumateperone
Trial Overview
The trial is testing lumateperone (42 mg daily) as an add-on treatment for depression in those with early life trauma. It compares lumateperone's effectiveness against a placebo and studies how it affects brain activity related to threat and reward learning.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Lumateperone, 42 mg, for 6 weeks to be taken orally once daily for 25 participants
25 Participants will receive a matching placebo capsule for 6 weeks to be taken orally once daily.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor
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