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NCT04280965 · ClinicalTrials.gov registry record · Early Phase 1

Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury

A Early Phase 1 study of Post Traumatic Stress Disorder, sponsored by The University of Texas Health Science Center at San Antonio.

Completed
Registry status
Early Phase 1
Development phase
28
Enrollment target
1
Study location

NCT04280965: Completed Early Phase 1 study of Post Traumatic Stress Disorder, sponsored by The University of Texas Health Science Center at San Antonio.

NCT04280965 is a Early Phase 1 study of Post Traumatic Stress Disorder that has completed, run by The University of Texas Health Science Center at San Antonio. The registered enrollment target is 28 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04280965, a Early Phase 1 study of Post Traumatic Stress Disorder, has completed, sponsored by The University of Texas Health Science Center at San Antonio.

COMPLETED
Registry status
Early Phase 1
Development phase
28 participants
Enrollment target
1
Study location

Study Summary

A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employs multiple medications commonly used for PTSD in the VA system.

Primary Outcome

The percentage of participants who complete the 10 sessions of Prolonged Exposure (PE) within 12-14 weeks of beginning treatment.

Interventions

  • DRUG Quetiapine Fumarate
  • OTHER Standard of care meducations

Study Locations (1)

Texas

  • UT Health San Antonio - San Antonio

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2019-02-01
Est. Completion 2022-10-17
Phase Early Phase 1

What the finished NCT04280965 record still lists

NCT04280965 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (96% lower).

The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 2 interventions - of which Quetiapine Fumarate is the first listed.

NCT04280965 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT04280965 about?

NCT04280965 is a clinical study titled "Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury". A pilot study to evaluate feasibility for a full-scale merit application. Specifically, for veterans considering prolonged exposure (PE) therapy, following the model established by Foa et al, we need to establish safety, and feasibility of quetiapine compared to treatment as usual (TAU) which employ...

What is the current status of trial NCT04280965?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 28 participants. The study started on 2019-02-01. Estimated completion is 2022-10-17.

What conditions does trial NCT04280965 study?

This clinical trial studies the following conditions: Post Traumatic Stress Disorder.

What interventions are being tested in trial NCT04280965?

The interventions under investigation include: Quetiapine Fumarate (DRUG), Standard of care meducations (OTHER).

Who is sponsoring clinical trial NCT04280965?

This trial is sponsored by The University of Texas Health Science Center at San Antonio, which has 378 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04280965 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Post Traumatic Stress Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04280965's enrollment target sits among peer trials

28 220th of 262 higher than 42 of 262 other Post Traumatic Stress Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder 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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Source: ClinicalTrials.gov NCT04280965, the US trial registry maintained by the National Library of Medicine. NCT04280965 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.