NCT00374543

Ziprasidone for the Treatment of Generalized Anxiety in Patients With Bipolar Disorder

Ziprasidone for the Treatment of Generalized Anxiety Comorbidity in Patients With Bipolar Disorder

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder
• Bipolar Disorder

Interventions

Type	Name	Description
DRUG	Ziprasidone	Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
DRUG	Placebo	Placebo administered daily for 8 weeks

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-10-01
• Completion: 2008-11-01
• First posted: 2006-09-11
• Last updated: 2014-04-16
• Results posted: 2014-04-16

Locations

1 site across 1 country: United States