Bipolar Disorder Clinical Trial
Official title:
Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder
This study proposes to examine the potential safety and efficacy of ziprasidone for patients with anxiety and bipolar disorder on anxiety outcomes, bipolar symptoms, and on measures of quality of life and resilience.
This study would be the first prospective, placebo-controlled study to our knowledge of any
pharmacotherapy strategy for the treatment of comorbid generalized anxiety (or any comorbid
anxiety) in patients with bipolar disorder. Our hypotheses are:
1. Ziprasidone flexibly dosed from 40 to 160 mg/day will reduce anxiety symptoms
significantly more than placebo in patients with bipolar disorder who have a full or
subsyndromal diagnosis of generalized anxiety disorder (GAD).
2. Ziprasidone will be well tolerated in patients with generalized anxiety based on the
incidence of treatment emergent adverse effects during 8 weeks of therapy, and based on
a lack of worsening of bipolar depression, mania or hypomania compared to placebo.
3. Treatment with ziprasidone will have a significantly greater positive impact on
measures of quality of life and resilience than placebo.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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