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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: Clinical Trial Phase 4 study, sponsored by University of Texas at Austin.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The MADRS is a 10-item questionnaire with each item scored between 0 and 6, resulting in a total score between 0 and 60, with scores above 34 indicating severe depression. Higher MADRS scores indicate more severe depression. The questionnaire is most frequently used in clinical studies to measure outcomes in antidepressant efficacy studies. This scale exhibits construct validity (internal homogeneity) and the concepts of endogenous and non-endogenous depression. The questionnaire includes questi
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 |
What is known before NCT07369115 opens enrollment
NCT07369115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07369115 does not publish any study locations in the registry export this page uses.
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
How this trial's enrollment target compares
Where NCT07369115's enrollment target sits among peer trials
50 1255th of 2000 higher than 678 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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