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

Early Phase 1

Completed

• Conditions: Post Traumatic Stress Disorder
• Interventions: Drug: Quetiapine Fumarate; Other: Standard of care meducations

• Registration Number: NCT04280965
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2020-02-19
• Study First Submitted QC: 2020-02-19
• Study First Posted: 2020-02-21
• Primary Completion: 2022-04-29
• Study Completion: 2022-10-17
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. All treatment seeking adult (≥ 18 years)
2. 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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quetiapine	Quetiapine Fumarate	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
Treatment As Usual (TAU)	Standard of care meducations	Standard of care medications

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States