Conditions: Bipolar Disorder
Keywords: Ziprasidone Bipolar Disorder Metabolic Syndrome
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 13
Healthy volunteers: no

Brief summary:
The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

Detailed description:
The trial was terminated prematurely on December 14, 2010, due to inability to recruit the planned number of subjects and shifting organizational priorities. The decision to terminate the trial was not based on any safety or efficacy concerns.

Arms:
arm 1: None

Interventions: intervention 1: Ziprasidone HCL (oral)
Intervention descriptions: intervention 1: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.

Protocol document: