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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bipolar Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active treatment (switch to oral Ziprasidone)

Group Type EXPERIMENTAL

Ziprasidone HCL (oral)

Intervention Type DRUG

Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.

Interventions

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Ziprasidone HCL (oral)

Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.

Intervention Type DRUG

Other Intervention Names

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Zeldox, Geodon

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No