Post-Traumatic Stress Disorder (PTSD) and Seroquel

Study Overview
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Brief Summary
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This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.

Detailed Description
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An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. If no obvious counterindications are present, subjects will be scheduled for a screening visit. After briefing the subjects on the reasons for the research, they will be given an opportunity to read the Informed Consent Form, approved by the Cambridge Health Alliance Institutional ReviewBoard, and to ask questions prior to signing it. Subjects will be given a copy of the signed Consent Form. Each subject will complete a standardized interview schedule designed to obtain personal and background data along with psychodiagnostic and psychometric evaluations. An open-label treatment will be utilized for all patients. Seroquel tablets will be flexibly dosed and begun at a target dose of 25 mg per day and taken over an 8 week period.

Official Title
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Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes

Conditions
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Post-Traumatic Stress Disorder

Intervention / Treatment
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* Drug: Seroquel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of written informed consent Fluency in English A diagnosis of PTSD No pregnancy Right-handedness Exclusion Criteria: Pregnancy or lactation Any cognitive impairment that precludes informed consent Known intolerance or lack of response to Seroquel Previous enrollment or randomization of treatment in the present study Participation in another drug trial within 4 weeks prior enrollment into this study Patients with Diabetes Mellitus History of allergic reaction or hypersensitivity to Seroquel Contraindications to magnetic resonance imaging Treatment with an effective medication for PTSD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seroquel<br>This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD | Drug: Seroquel<br>* This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD<br>* Other names: quetiapine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint. | We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-traumatic Stress Disorder, PTSD, Seroquel, fMRI