Conditions: Generalized Anxiety Disorder Bipolar Disorder
Keywords: Bipolar Disorder Generalized Anxiety Disorder Double-blind Placebo-controlled Ziprasidone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Ziprasidone will be dosed on a twice daily (BID) basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day, for 8 weeks. This time period reflects the rapid onset of effect seen in studies of atypical antipsychotics, but allows time for a potentially longer response for some anxiety symptoms. arm 2: Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.

Interventions: intervention 1: Ziprasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks. intervention 2: Placebo administered daily for 8 weeks

Protocol document: