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One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT01113541•Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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.

Locations (10)

Foothills Medical Centre, Department of Psychiatry

Calgary, Alberta, Canada

Mental Health Centre for Research and Education

Calgary, Alberta, Canada

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, Canada

Country Club Plaza

Winnipeg, Manitoba, Canada

Edgeland Medical, Dr. Alla Kirshner Medical Corporation

Winnipeg, Manitoba, Canada

Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic

Halifax, Nova Scotia, Canada

Office of Dr. A. K. Munshi

Sydney, Nova Scotia, Canada

Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine

Montreal, Quebec, Canada

Clinique St-Leonard

Montreal, Quebec, Canada

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Key Dates

Start Date

July 1, 2010

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

March 3, 2021

Enrollment

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Ziprasidone HCL (oral)

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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Early Intervention for Youth at High Risk for Bipolar Disorder