One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

A One-year, Phase III, Open-label, Non-comparative Trial of the Effect of Ziprasidone HCl on Metabolic Syndrome Risk Factors in Patients With Bipolar Disorder

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.

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.

Inclusion Criteria:

• Subject must present at least 2 of the following risk factors of MS at screening: Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥ 5.6 mmol/L.
• According to the clinical judgment of the investigator, the risk factors for MS have developed in close temporal relationship to starting an antipsychotic medication.
• Substitution to a less metabolically disruptive antipsychotic medication is considered

Exclusion Criteria:

• Subjects with contraindication(s) to the use of Ziprasidone according to Canadian prescribing information.
• Subjects with a history of treatment resistance.
• Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that may confound the evaluation of the study drug.
• Body mass index ≥ 40 at baseline.