Clinical trial NCT01113541: One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Ziprasidone
Bipolar Disorder
Metabolic Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-30
Enrollment: 13
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 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 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 Who Achieved a Reduction From Baseline of at Least 1 Risk Factor for Metabolic Syndrome (MS) at Week 52 or Premature Discontinuation
timeFrame: Week 52 or Early Termination
Secondary outcomes:
measure: Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)
timeFrame: Baseline, Week 52
measure: Metabolic Syndrome (MS) Prevalence
timeFrame: Baseline through Week 52
measure: Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor
timeFrame: Baseline through Week 52
measure: Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors
timeFrame: Baseline through Week 52
measure: Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference
timeFrame: Baseline, Week 4, Week 12, Week 52
measure: Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure
timeFrame: Baseline, Week 4, Week 12, Week 52
measure: Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose
timeFrame: Baseline, Week 4, Week 12, Week 52
measure: Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)
timeFrame: Baseline, Week 4, Week 12, Week 52
measure: Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides
timeFrame: Baseline, Week 4, Week 12, Week 52
measure: Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System
timeFrame: Baseline, Week 4, Week 52
measure: Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels
timeFrame: Baseline, Week 52 or Early Termination
measure: Change From Baseline in Weight
timeFrame: Baseline, Week 4, Week 12, Week 52 or Early Termination
measure: Change From Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 4, Week 12, Week 52 or Early Termination
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, Week 52 or Early Termination
measure: Change From Baseline in Insulin Levels
timeFrame: Baseline, Week 52 or Early Termination
measure: Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)
timeFrame: Baseline, Week 4, Week 52 or Early Termination
measure: Change From Baseline in Apolipoprotein B (ApoB) Levels
timeFrame: Baseline, Week 52 or Early Termination
measure: Change From Baseline in Leptin
timeFrame: Baseline, Week 52 or Early Termination
measure: Change From Baseline in Physical Activity Index
timeFrame: Baseline, Week 28, Week 52 or Early Termination
measure: Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
timeFrame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
measure: Change From Baseline in Young Mania Rating Scale (YMRS)
timeFrame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale
timeFrame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
measure: Clinical Global Impression - Improvement (CGI-I) Subscale Score
timeFrame: Week 52 or Early Termination
measure: Change From Baseline in Drug Attitude Inventory (DAI)
timeFrame: Week 28, Week 52 or Early Termination
measure: Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)
timeFrame: Baseline, Week 28, Week 52 or Early Termination
measure: Change From Baseline in EuroQoL Index (EQ-I)
timeFrame: Baseline, Week 28, Week 52 or Early Termination
measure: Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
timeFrame: Baseline, Week 28, Week 52 or Early Termination
measure: Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale
timeFrame: Baseline, Week 28, Week 52 or Early Termination
measure: Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])
timeFrame: Baseline, Week 1 through Week 52 or Early Termination
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre, Department of Psychiatry
state: Alberta
city: Calgary
country: Canada
facility: Mental Health Centre for Research and Education
state: Alberta
city: Penticton
country: Canada
facility: Dr. Alexander McIntyre Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Country Club Plaza
state: Manitoba
city: Winnipeg
country: Canada
facility: Edgeland Medical, Dr. Alla Kirshner Medical Corporation
state: Manitoba
city: Halifax
country: Canada
facility: Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic
state: Nova Scotia
city: Sydney
country: Canada
facility: Office of Dr. A. K. Munshi
state: Nova Scotia
city: Montreal
country: Canada
facility: Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine
state: Quebec
city: Montreal
country: Canada
facility: Clinique St-Leonard
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Research Sherbrooke Inc.
state: Quebec
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: