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

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ClinicalTrials.gov Identifier: NCT04280965

Recruitment Status : Recruiting

First Posted : February 21, 2020

Last Update Posted : March 1, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

The University of Texas Health Science Center at San Antonio

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	20 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 :	February 1, 2019
Estimated Primary Completion Date :	December 31, 2021
Estimated Study Completion Date :	December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

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 Name: 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 [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04280965

Contacts

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Contact: Muhammad Baig, MD	210-617-5300 ext 18244	muhammad.baig@va.gov

Locations

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United States, Texas
UT Health San Antonio	Recruiting
San Antonio, Texas, United States, 78229
Contact: Anna Hernandez, RN 210-567-0780 hernandeza3@uthscsa.edu

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Baig MR, Beck RD, Wilson JL, Lemmer JA, Meraj A, Meyer EC, Mintz J, Peterson AL, Roache JD. Quetiapine augmentation of prolonged exposure therapy in veterans with PTSD and a history of mild traumatic brain injury: design and methodology of a pilot study. Mil Med Res. 2020 Oct 8;7(1):46. doi: 10.1186/s40779-020-00278-0.

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Responsible Party:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT04280965
Other Study ID Numbers:	18-200H
First Posted:	February 21, 2020 Key Record Dates
Last Update Posted:	March 1, 2021
Last Verified:	February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
Plan Description:	All IPD that underlie results in publication
Supporting Materials:	Statistical Analysis Plan (SAP)
Time Frame:	Anticipated June 2021
Access Criteria:	Acceptance for publication by journal

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Brain Injuries Brain Injuries, Traumatic Brain Concussion Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries	Trauma and Stressor Related Disorders Mental Disorders Head Injuries, Closed Wounds, Nonpenetrating Quetiapine Fumarate Antidepressive Agents Psychotropic Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs

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