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Sponsors and Collaborators: |
University Hospital Case Medical Center National Alliance for Research on Schizophrenia and Depression |
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Information provided by: | University Hospital Case Medical Center |
ClinicalTrials.gov Identifier: | NCT00671853 |
The primary objective is to test the hypothesis that Quetiapine XR (Extended Release) monotherapy and adjunctive therapy is effective in the acute treatment of bipolar depression and comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. The secondary aim is to generate an estimate of effect size to power a definitive large-scale, multi-site collaborative R01 and to configure the use of the primary and secondary outcome measures in the definitive large-scale study.
Condition | Intervention | Phase |
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Bipolar Disorder Anxiety Anxiety Disorders Substance Use Disorders |
Drug: Quetiapine XR Drug: Placebo for quetiapine XR |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment |
Official Title: | Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Quetiapine XR
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Drug: Quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
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2: Placebo Comparator
Placebo for quetiapine XR
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Drug: Placebo for quetiapine XR
Days 1-2 - 50 mg/day; Days 3-4 - 150mg/day; Day 5-End of Study - 300mg/day
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120 subjects aged 18 and up with DSM-IV Generalized Anxiety Disorder and Bipolar Disorder type I or II as identified by extensive clinical interview and the Mini-International Neuropsychiatric Interview (MINI) will be enrolled and randomized. Assignment to each arm will be balanced for BP I vs BP II; male vs female; and with vs without SUD. Potential participants will be recruited by means of IRB-approved advertising or from the clinical psychiatric infrastructure.
This study is a randomized, double-blind, placebo-controlled, 8-week comparison of quetiapine SR monotherapy or adjunctive mood stabilizer therapy vs. placebo in the acute treatment of comorbid generalized anxiety disorder in patients with bipolar disorder with or without a substance use disorder. Subjects will be assessed weekly for mood changes and side effects.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Liz Fein, MA | 216-844-2863 | Elizabeth.Fein@UHhospitals.org |
United States, Ohio | |
University Hospitals Case Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact: Liz Fein, MA 216-844-2863 Elizabeth.Fein@UHhospitals.org | |
Principal Investigator: Keming Gao, PhD, MD |
Principal Investigator: | Keming Gao, PhD, MD | University Hospitals Case Medical Center |
Responsible Party: | University Hospital Case Medical Center ( Keming Gao, Ph.D., M.D. ) |
Study ID Numbers: | 10-06-19 |
Study First Received: | May 1, 2008 |
Last Updated: | July 21, 2009 |
ClinicalTrials.gov Identifier: | NCT00671853 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Bipolar Disorder Anxiety Anxiety Disorders Substance Use Disorders |
Depression Tranquilizing Agents Bipolar Disorder Psychotropic Drugs Central Nervous System Depressants Disorders of Environmental Origin Depressive Disorder Antipsychotic Agents |
Affective Disorders, Psychotic Quetiapine Anxiety Disorders Mental Disorders Substance-Related Disorders Mood Disorders Psychotic Disorders |
Disease Tranquilizing Agents Bipolar Disorder Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Central Nervous System Depressants Antipsychotic Agents Pharmacologic Actions |
Affective Disorders, Psychotic Quetiapine Pathologic Processes Anxiety Disorders Mental Disorders Therapeutic Uses Substance-Related Disorders Mood Disorders Central Nervous System Agents |