Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic… (NCT00579280) | Clinical Trial Compass
CompletedPhase 4
Quetiapine SR and Divalproex Sodium ER in the Treatment of Anxiety in Bipolar Disorder With Panic Disorder and/or GAD
United States224 participantsStarted 2007-07
Plain-language summary
The specific aim of this study is to evaluate the efficacy, tolerability, and safety of quetiapine SR monotherapy and divalproex sodium ER monotherapy in comparison to placebo in the treatment of ambulatory bipolar disorder with co-morbid lifetime panic disorder or generalized anxiety disorder and current at least moderately severe anxiety.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Subjects must be at least 18 years of age and not older than 65
* Subjects must have lifetime bipolar I, II, or not otherwise specified (NOS) disorder as defined by DSM-IV TR (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision) criteria
* Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV, criteria (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD)
* Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP\< 4
* Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S \> 4
* Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline
* Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained
* If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study
Exclusion Criteria:
* Subjects who do not have lifetime bipolar disorder by DSM-IV-TR criter…