Overview

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

Status:
Terminated
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Treatments:
Ziprasidone
Criteria
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.