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

NCT01113541 | Terminated Phase 3 Results

• 1 other identifier: A1281190
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Bipolar Disorder

Keywords

Ziprasidone; Bipolar Disorder; Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation

  MS risks factors: elevated (el) waist circumference: ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm \[men\] and ≥80 cm \[women\]); el triglycerides: ≥1.7 millimoles per liter (mmol/L) (1≥50 milligrams per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men and \<1.3 mmol/L (\<50 mg/dL) in women; el fasting glucose: ≥5.6 mmol/L (≥100 mg/dL); and el systolic/diastolic blood pressure: systolic ≥130 millimeters of mercury (mmHg) and/or diastolic ≥85 mmHg. Responder = at least 1 less risk factor at endpoint than baseline.

  Week 52 or Early Termination

Secondary Outcomes (29)

• Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)

  Baseline, Week 52

• Metabolic Syndrome (MS) Prevalence

  Baseline through Week 52

• Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor

  Baseline through Week 52

• Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors

  Baseline through Week 52

• Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference

  Baseline, Week 4, Week 12, Week 52

Study Arms (1)

Active treatment (switch to oral Ziprasidone)

EXPERIMENTAL

Drug: Ziprasidone HCL (oral)

Interventions

Ziprasidone HCL (oral) DRUG

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

Also known as: Zeldox, Geodon

Active treatment (switch to oral Ziprasidone)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (10)

Foothills Medical Centre, Department of Psychiatry

Calgary, Alberta, T2N 2T9, Canada

Location

Mental Health Centre for Research and Education

Calgary, Alberta, T2N 2T9, Canada

Location

Dr. Alexander McIntyre Inc.

Penticton, British Columbia, V2A 4M4, Canada

Location

Country Club Plaza

Winnipeg, Manitoba, R3K 2E2, Canada

Location

Edgeland Medical, Dr. Alla Kirshner Medical Corporation

Winnipeg, Manitoba, R3P 0N5, Canada

Location

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

Halifax, Nova Scotia, B3H 2E2, Canada

Location

Office of Dr. A. K. Munshi

Sydney, Nova Scotia, B1S 2E8, Canada

Location

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

Montreal, Quebec, H1N 3V2, Canada

Location

Clinique St-Leonard

Montreal, Quebec, H1P 3K2, Canada

Location

Diex Research Sherbrooke Inc.

Sherbrooke, Quebec, J1H 1Z1, Canada

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Bipolar Disorder; Metabolic Syndrome

Interventions

ziprasidone

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

This study was terminated due to slow enrollment and changes in organizational strategy and resources; most of the planned analyses in the statistical analysis plan were not performed.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2010
• First Posted: April 30, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: March 3, 2021
• Results First Posted: July 9, 2012

Record last verified: 2021-03

Locations

CA (10)