Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT07369115 · ClinicalTrials.gov registry record · Phase 4
Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse
A Phase 4 study, sponsored by University of Texas at Austin.
- Not yet
- Registry status
- Phase 4
- Development phase
- 50
- Enrollment target
NCT07369115 is a Phase 4 study that has not yet begun recruiting, run by University of Texas at Austin. The registered enrollment target is 50 participants.
The verdict
NCT07369115, a Phase 4 study, has not yet begun recruiting, sponsored by University of Texas at Austin.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- DRUG Lumateperone 42 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2026-02 |
| Est. Completion | 2030-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07369115
The ClinicalTrials.gov registry entry for NCT07369115 describes a study currently listed as not yet recruiting, categorized as Phase 4. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas at Austin, which has 257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07369115 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07369115 about?
NCT07369115 is a clinical study titled "Neurocircuitry Mechanisms and Efficacy of Lumateperone as Adjunctive Therapy for Major Depressive Disorder and History of Early Life Abuse". 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...
What is the current status of trial NCT07369115?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 50 participants. The study started on 2026-02. Estimated completion is 2030-01.
What interventions are being tested in trial NCT07369115?
The interventions under investigation include: Placebo (OTHER), Lumateperone 42 mg (DRUG).
Who is sponsoring clinical trial NCT07369115?
This trial is sponsored by University of Texas at Austin, which has 257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.