Status:
COMPLETED
Quetiapine Augmentation of PE Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury
Lead Sponsor:
The University of Texas Health Science Center at San Antonio
Collaborating Sponsors:
South Central MIRECC
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- (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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT04280965
Start Date
February 1 2019
End Date
October 17 2022
Last Update
May 9 2023
Active Locations (1)
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1
UT Health San Antonio
San Antonio, Texas, United States, 78229