Anxiety Clinical Trial
Official title:
Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder
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.
120 subjects aged 18 and up with Diagnostic and Statistical Manual -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 Institutional Review Board
-approved advertising or from the clinical psychiatric infrastructure.
This study is a randomized, double-blind, placebo-controlled, 8-week comparison of
quetiapine sustained-release 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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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