UT Health San Antonio
San Antonio, Texas, 78229, United States
NCT Number: NCT04280965
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
San Antonio, Texas, 78229, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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.
Atypical antipsychotic
Other names: Seroquel
SSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine
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.
The University of Texas Health Science Center at San Antonio
Other
Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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