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Sponsors and Collaborators: |
Indiana University AstraZeneca |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00619892 |
The primary objective of this study is to test the hypothesis that a SSRI plus quetiapine SR (Seroquel SR) will result in superior early (first 1-3 weeks of treatment) stabilization of panic symptoms in SSRI-resistant, comorbid Panic Disorder patients versus a SSRI plus placebo.
Condition | Intervention | Phase |
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Panic Disorder |
Drug: quetiapine SR Drug: placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment |
Official Title: | An 8-Week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-Administration for SSRI-Resistant, Comorbid Panic Disorder |
Estimated Enrollment: | 30 |
Study Start Date: | February 2008 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: quetiapine SR
Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
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2: Placebo Comparator |
Drug: placebo
Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
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Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Contact: Carla E Medlock, BA, CCRP | (317) 274-0314 | cemedloc@iupui.edu |
United States, Indiana | |
University Hospital Outpatient Center, Psychiatry | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Carla E Medlock, B.A. 317-274-0314 cemedloc@iupui.edu |
Principal Investigator: | Andrew W. Goddard, M.D. | Indiana University |
Responsible Party: | Indiana University School of Medicine, Department of Psychiatry ( Andrew W. Goddard / Professor of Psychiatry ) |
Study ID Numbers: | IRUSQUET0445, 4587082 |
Study First Received: | February 11, 2008 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00619892 History of Changes |
Health Authority: | United States: Institutional Review Board |
SSRI Resistant Seroquel SR Seroquel XR Panic Disorder |
Comorbid Panic Disorder Quetiapine SR Quetiapine XR |
Quetiapine Panic Disorder Tranquilizing Agents Anxiety Disorders Mental Disorders |
Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Serotonin Uptake Inhibitors |
Disease Tranquilizing Agents Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Panic Disorder Quetiapine Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Central Nervous System Agents |