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

NCT04280965 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 18-200H
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• Percentage compliance in completing PE sessions

  The percentage of participants who complete the 10 sessions of Prolonged Exposure (PE) within 12-14 weeks of beginning treatment.

  1.5 yr

Study Arms (2)

Quetiapine

EXPERIMENTAL

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

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Standard of care medications

Other: Standard of care meducations

Interventions

Quetiapine Fumarate DRUG

Atypical antipsychotic

Also known as: Seroquel

Quetiapine

Standard of care meducations OTHER

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

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• South Central MIRECC: collaborator

Study Sites (1)

UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• 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.

  PMID: 33032657 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Muhammad Baig, MD

  South Texas Veterans Health Care System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2020
• First Posted: February 21, 2020
• Study Start: February 1, 2019
• Primary Completion: April 29, 2022
• Study Completion: October 17, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Anticipated June 2023
• Access Criteria: Acceptance for publication by journal

Locations

US (1)