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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Post Traumatic Stress Disorder

Treatments: Drug: Quetiapine Fumarate; Other: Standard of care meducations

Study type: Interventional

Funder types: Other

Identifiers

NCT04280965

18-200H

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Quetiapine

Experimental group

Description:

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:

Drug: Quetiapine Fumarate

Treatment As Usual (TAU)

Active Comparator group

Description:

Standard of care medications

Treatment:

Other: Standard of care meducations