Generalized Anxiety and Seroquel

Study Overview
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Brief Summary
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The 12 week clinical trial of Seroquel in Generalized Anxiety Disorder (GAD) patients will be combined with fMRI experiments.

Detailed Description
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Subjects will be recruited from clinic patients and known research subjects at McLean Hospital, as well as by advertisements in the media, flyers, and word of mouth. An initial telephone interview will be conducted to determine if potential subjects meet the basic study requirements. Subjects will be also screened for drug use. If no obvious health problems are present, subjects will be scheduled for an evaluation. Upon arrival at the research unit, each subject will first complete a standardized interview schedule designed to obtain personal and background data such as age, marital status, socio-economic status, education, employment, etc. The Research Assistant will give subjects both verbal and written descriptions of the study procedures. After briefing subjects on the reasons for the research, subjects will be given the opportunity to ask questions. When they are ready, subjects will be asked to sign the written informed consent form approved by the Mclean Institutional Review Board (IRB). Functional magnetic resonance imaging scans to examine brain functioning will be obtained from GAD patients (N=30) at baseline and after 12 weeks. Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.

Official Title
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Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function

Conditions
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Generalized Anxiety Disorder, Seroquel XR

Intervention / Treatment
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* Drug: Seroquel XR


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 GAD No pregnancy Right-handedness Psychotropic medication-free at the start of the study Exclusion Criteria: Pregnancy or lactation Any current DSM-IV-TR Axis I disorder Any mental retardation or cognitive impairment that precludes informed consent Known intolerance or lack of response to quetiapine fumarate Substance or alcohol dependence at enrollment Participation in another drug trial within 4 weeks prior enrollment History of allergic reaction or hypersensitivity to Seroquel or Seroquel XR History of prior Seroquel or other antipsychotic agents use Contraindications to magnetic resonance imaging Treatment with an effective medication for GAD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 XR<br> | Drug: Seroquel XR<br>* Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in GAD Symptomatology at the Week 12 Timepoint. | Changes in anxiety symptomatolgy | 12 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fMRI, Seroquel, Generalized Anxiety Disorder