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

Sponsor

The University of Texas Health Science Center at San Antonio (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04280965

Collaborator

South Central MIRECC (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Post Traumatic Stress Disorder	Drug: Quetiapine Fumarate Other: Standard of care meducations	Early Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2019

Actual Primary Completion Date :

Apr 29, 2022

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Quetiapine Flexible dosing begins at 50 mg, titrating up to 100 mg at the end of week 2 with additional doses up to 400 mg per day if needed	Drug: Quetiapine Fumarate Atypical antipsychotic Other Names: Seroquel
Active Comparator: Treatment As Usual (TAU) Standard of care medications	Other: Standard of care meducations SSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine

Arm

Intervention/Treatment

Experimental: Quetiapine

Flexible dosing begins at 50 mg, titrating up to 100 mg at the end of week 2 with additional doses up to 400 mg per day if needed

Drug: Quetiapine Fumarate

Atypical antipsychotic

Other Names:

Seroquel

Active Comparator: Treatment As Usual (TAU)

Standard of care medications

Other: Standard of care meducations

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

Outcome Measures

Primary Outcome Measures

Percentage compliance in completing PE sessions [1.5 yr]
The percentage of participants who complete the 10 sessions of Prolonged Exposure (PE) within 12-14 weeks of beginning treatment.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

All treatment seeking adult (≥ 18 years)
Veterans with mTBI who meet PTSD diagnosis and have a CAPS-5 score of 25 or greater. Diagnosis will be determined using the provisional PTSD diagnosis convention recommended by the National Center of PTSD which requires at least moderate ratings (2 or more) on at least 1 B item (items #1-5), 1 C item (items #6-7), 2 D items (#8-14), and 2 E items (items #15-20) of the Clinician Administered PTSD Scale for DSM-5 (CAPS-5).

Exclusion Criteria: (1) Pregnant or lactating women and those of child-bearing potential not using a reliable method of contraception; (2) Individuals meeting DSM-5 criteria for schizophrenia, schizoaffective disorder, or neurocognitive disorder; (3) Individuals currently taking any typical or atypical antipsychotic medication or individuals using daily benzodiazepines including nonbenzodiazepine z-drugs for sleep as they have effects similar to benzodiazepines for sleep. (Note: benzodiazepine use is contraindicated as they may impair learning required for progress with PE) (4) Individuals with known intolerance to quetiapine or a history of clinically unstable heart, lung, liver, renal or endocrinological condition, diabetes mellitus, and/or seizure disorder. (5) Individuals with substance use disorder severe enough to require medical detoxification.

(6) Individuals who report suicidal or homicidal ideations in the past month severe enough to warrant inpatient admission.

(7) Individuals with current or known history of cardiac arrhythmia or QTc interval ≥ 450 milliseconds. (Note) Patients requiring other anti-arousal medication for general medical conditions such as antihypertensive medications, beta blockers etc., for hypertension, anti-thyroid medications for hyperthyroidism, and/or anti-epileptic medications, divalproex, levetiracetam, or carbamazepine for seizure disorder may be included if stable for at least 1 month before the screening visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UT Health San Antonio	San Antonio	Texas	United States	78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio
South Central MIRECC

Investigators

Principal Investigator: Muhammad Baig, MD, South Texas Veterans Health Care System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Texas Health Science Center at San Antonio

ClinicalTrials.gov Identifier:

NCT04280965

Other Study ID Numbers:

18-200H

First Posted:

Feb 21, 2020

Last Update Posted:

May 5, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Brain Injuries

Brain Injuries, Traumatic

Brain Concussion

Stress Disorders, Traumatic

Stress Disorders, Post-Traumatic

Quetiapine Fumarate

Study Results

No Results Posted as of May 5, 2022