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

NCT04280965 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-05-09

No results posted yet for this 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.

Conditions

  • Post Traumatic Stress Disorder

Interventions

DRUG

Quetiapine Fumarate

Atypical antipsychotic

OTHER

Standard of care meducations

SSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine

Sponsors & Collaborators

  • South Central MIRECC

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Muhammad Baig, MD · South Texas Veterans Health Care System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2022-04-29
Completion
2022-10-17
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04280965 on ClinicalTrials.gov