Clinical trial NCT00748566: One-Year Trial Of Oral Ziprasidone In Patients With Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia and Disorders With Psychotic Features
Keywords: Ziprasidone
metabolic syndrome
risk factors
schizophrenia
psychotic disorders.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-09-08
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
timeFrame: Endpoint (premature discontinuation or Week 52)
Secondary outcomes:
measure: Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Percentage of Participants With Metabolic Syndrome (MS)
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52
timeFrame: Week 4, 12, 28, 52
measure: Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Weight at Week 4,12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Insulin Level at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in the Physical Activity Index Score at Week 28 and 52
timeFrame: Baseline, Week 28, 52
measure: Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52
timeFrame: Baseline, Week 4, 12, 28, 52
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52
timeFrame: Baseline, Week 12, 28, 52
measure: Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52
timeFrame: Baseline, Week 12, 28, 52
measure: Clinical Global Impression-Improvement (CGI-I) Scale Score
timeFrame: Endpoint (premature discontinuation or Week 52)
measure: Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52
timeFrame: Baseline, Week 28, 52
measure: Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52
timeFrame: Baseline, Week 28, 52
measure: Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52
timeFrame: Baseline, Week 28, 52
measure: Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52
timeFrame: Baseline, Week 28, 52
measure: Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
timeFrame: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Medicine Hat
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Medicine Hat
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Red Deer
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Penticton
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Victoria
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Bathurst
country: Canada
facility: Pfizer Investigational Site
state: New Brunswick
city: St. John's
country: Canada
facility: Pfizer Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Sydney
country: Canada
facility: Pfizer Investigational Site
state: Nova Scotia
city: Burlington
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Chatham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: London
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Markham
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Windsor
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Verdun
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saskatoon
country: Canada
facility: Pfizer Investigational Site
state: Saskatchewan
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Chue P, Mandel FS, Therrien F. The effect of ziprasidone on metabolic syndrome risk factors in subjects with schizophrenia: a 1 year, open-label, prospective study. Curr Med Res Opin. 2014 Jun;30(6):997-1005. doi: 10.1185/03007995.2014.898139. Epub 2014 Mar 17.