One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
This study has been terminated.
(See Detailed Description)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00748566
First received: September 5, 2008
Last updated: April 23, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia and Disorders With Psychotic Features |
Drug: Ziprasidone HCL (oral) |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A One-Year, Phase IV, Open-Label, Non-Comparative Trial Of The Effect Of Ziprasidone HCL On Metabolic Syndrome Risk Factors In Patients With Psychotic Disorders |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes Medicines
Mental Disorders
Metabolic Syndrome
Psychotic Disorders
Schizophrenia
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of subjects achieving a reduction from baseline of at least 1 risk factor for metabolic syndrome at endpoint. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Changes from baseline in EuroQoL Index (EQ-I) and Visual Analog Scale (VAS). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Change from baseline in 10-year CHD risk according to Framingham scoring system. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in Total cholesterol and LDL-cholesterol levels. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in weight and body mass index. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in HbA1c and insulin level. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Change from baseline in the Physical Activity Index. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Incidence of adverse events (AEs) and discontinuations from the study. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in Social and Occupational Functioning Assessment Scale (SOFAS). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Mean change from baseline in the number of risk factors of metabolic syndrome (MS). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Metabolic Syndrome rate (MS prevalence). [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in Drug-Attitude Inventory - 30-item version (DAI-30). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Changes from baseline in Positive and Negative Syndrome Scale (PANSS) total score, positive and negative subscale scores. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Change from baseline in Clinical Global Impression-Severity (CGI-S) and -Improvement subscale (CGI-I) scores at endpoint. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Individual MS risk factors: Waist circumference, triglycerides, HDL-Cholesterol, systolic/ diastolic blood pressure, fasting glucose. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Changes from baseline in Columbia Suicide Severity Rating Scale (C SSRS) score [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Change from baseline in corrected QT interval (QTc) [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Enrollment: | 172 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Active treatment (switch to oral Ziprasidone) |
Drug: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Other Name: Zeldox, Geodon
|
Detailed Description:
The trial was terminated prematurely on May 24, 2012, due to changes in organizational strategy and resources. The decision to terminate the trial was not based on any safety or efficacy concerns.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00748566
Locations
| Canada, Alberta | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 4Z6 | |
| Pfizer Investigational Site | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Pfizer Investigational Site | |
| Medicine Hat, Alberta, Canada, T1A 4C2 | |
| Pfizer Investigational Site | |
| Medicine Hat, Alberta, Canada, T1B 4E7 | |
| Pfizer Investigational Site | |
| Red Deer, Alberta, Canada, T4N 1T6 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Penticton, British Columbia, Canada, V2A 4M4 | |
| Pfizer Investigational Site | |
| Victoria, British Columbia, Canada, V8R 4Z3 | |
| Canada, Manitoba | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3A 1R9 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3E 3N4 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3P 0N5 | |
| Pfizer Investigational Site | |
| Winnipeg, Manitoba, Canada, R3K 2E2 | |
| Canada, New Brunswick | |
| Pfizer Investigational Site | |
| Bathurst, New Brunswick, Canada, E2A 2Z6 | |
| Canada, Newfoundland and Labrador | |
| Pfizer Investigational Site | |
| St. John's, Newfoundland and Labrador, Canada, A1E 4J8 | |
| Canada, Nova Scotia | |
| Pfizer Investigational Site | |
| Halifax, Nova Scotia, Canada, B3H 2E2 | |
| Pfizer Investigational Site | |
| Sydney, Nova Scotia, Canada, B1P 1E1 | |
| Pfizer Investigational Site | |
| Sydney, Nova Scotia, Canada, B1P 1C6 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Burlington, Ontario, Canada, L7R 4E2 | |
| Pfizer Investigational Site | |
| Chatham, Ontario, Canada, N7L 1B7 | |
| Pfizer Investigational Site | |
| Kingston, Ontario, Canada, K7L 4X3 | |
| Pfizer Investigational Site | |
| London, Ontario, Canada, N6A 4G5 | |
| Pfizer Investigational Site | |
| Markham, Ontario, Canada, L6B 1A1 | |
| Pfizer Investigational Site | |
| Mississauga, Ontario, Canada, L5M 4N4 | |
| Pfizer Investigational Site | |
| Ottawa, Ontario, Canada, K1H 8K7 | |
| Pfizer Investigational Site | |
| Sudbury, Ontario, Canada, P3E 1X3 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M6J 1H4 | |
| Pfizer Investigational Site | |
| Toronto, Ontario, Canada, M5T 1R8 | |
| Pfizer Investigational Site | |
| Windsor, Ontario, Canada, N9C 3Z4 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H3A 1A1 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1N 3V2 | |
| Pfizer Investigational Site | |
| Montreal, Quebec, Canada, H1N 3M5 | |
| Pfizer Investigational Site | |
| Verdun, Quebec, Canada, H4H 1R3 | |
| Canada, Saskatchewan | |
| Pfizer Investigational Site | |
| Saskatoon, Saskatchewan, Canada, S7K 3H3 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00748566 History of Changes |
| Other Study ID Numbers: | A1281173 |
| Study First Received: | September 5, 2008 |
| Last Updated: | April 23, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Pfizer:
|
Ziprasidone metabolic syndrome risk factors schizophrenia psychotic disorders. |
Additional relevant MeSH terms:
|
Psychotic Disorders Mental Disorders Schizophrenia Metabolic Syndrome X Schizophrenia and Disorders with Psychotic Features Insulin Resistance Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases Ziprasidone Serotonin Antagonists Serotonin Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs Dopamine Antagonists Dopamine Agents |
ClinicalTrials.gov processed this record on May 19, 2013