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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Ziprasidone, flexibly dosed from 40 to 160 mg/day, for 8 weeks.
Placebo administered daily for 8 weeks
Center for Anxiety and Traumatic Stress Disorders at Massachusetts General Hospital
Boston, Massachusetts, United States
Hamilton Anxiety Rating Scale (HAM-A)
The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD. Due to study termination, there are not results for primary and secondary outcome measures.
Time frame: 8 weeks
Clinical Global Impression of Improvement (CGI-I)
A secondary categorical outcome of response will be defined as a Clinical Global Impression Improvement Score (CGI-I) of 1 or 2. The CGI-I is a 7 point clinician-rated scale that assesses symptom improvement or worsening relative to a previous assessment. Lower ratings reflect greater improvement. Due to study termination, there are not results for primary and secondary outcome measures.
Time frame: 8 weeks
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