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

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NCT01113541

Last updated on October 4, 2018
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FOR MORE INFORMATION
Study Location
Foothills Medical Centre, Department of Psychiatry
Calgary, Alberta, T2N 2T9 Canada
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Bipolar Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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: ( 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01113541
Pfizer
Terminated
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

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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.
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bipolar Disorder
Drug: 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.
Other Name: Zeldox, Geodon
Experimental: Active treatment (switch to oral Ziprasidone)
Intervention: Drug: Ziprasidone HCL (oral)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
13
February 2011
February 2011   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT01113541
A1281190
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
June 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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