Back to resultsOne-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Primary Purpose
Bipolar Disorder
Status
Terminated
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Ziprasidone HCL (oral)
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Ziprasidone, Bipolar Disorder, Metabolic Syndrome
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.
Sites / Locations
- Foothills Medical Centre, Department of Psychiatry
- Mental Health Centre for Research and Education
- Dr. Alexander McIntyre Inc.
- Country Club Plaza
- Edgeland Medical, Dr. Alla Kirshner Medical Corporation
- Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic
- Office of Dr. A. K. Munshi
- Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine
- Clinique St-Leonard
- Diex Research Sherbrooke Inc.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Active treatment (switch to oral Ziprasidone)
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Metabolic Syndrome (MS) Prevalence
Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.
Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors
MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference
MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure
MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose
MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)
MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides
MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).
Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System
Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels
Change From Baseline in Weight
Change From Baseline in Body Mass Index (BMI)
Body mass index = weight in kilograms (kg) / height in meters (m)^2 .
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Change From Baseline in Insulin Levels
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)
QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.
Change From Baseline in Apolipoprotein B (ApoB) Levels
Change From Baseline in Leptin
Change From Baseline in Physical Activity Index
Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Change From Baseline in Young Mania Rating Scale (YMRS)
11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Clinical Global Impression - Improvement (CGI-I) Subscale Score
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Change From Baseline in Drug Attitude Inventory (DAI)
DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)
0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.
Change From Baseline in EuroQoL Index (EQ-I)
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale
31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.
Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
Full Information
NCT ID
NCT01113541
First Posted
April 28, 2010
Last Updated
March 2, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01113541
Brief Title
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
See termination reason in detailed description.
Study Start Date
July 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Ziprasidone, Bipolar Disorder, Metabolic Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active treatment (switch to oral Ziprasidone)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ziprasidone HCL (oral)
Other Intervention Name(s)
Zeldox, Geodon
Intervention Description
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Week 52 or Early Termination
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS)
Description
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Time Frame
Baseline, Week 52
Title
Metabolic Syndrome (MS) Prevalence
Description
Percentage of participants at each visit defined as having metabolic syndrome (MS) based on the National Cholesterol Education Program (NCEP) Adult Treatment Panel III. MS = 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose.
Time Frame
Baseline through Week 52
Title
Change From Baseline in the Percentage of Participants With Each Individual Metabolic Syndrome (MS) Risk Factor
Description
MS risks factors: elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Time Frame
Baseline through Week 52
Title
Percentage of Participants With Individual Metabolic Syndrome (MS) Risk Factors
Description
MS risks factors = elevated waist circumference: ≥102 cm in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]); elevated triglycerides: ≥1.7 mmol/L (1≥50 mg/dL); reduced HDL-C: <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 (≥100 mg/dL); and elevated systolic/diastolic blood pressure: systolic blood pressure ≥130 mm Hg and/or diastolic blood pressure ≥85 mm Hg.
Time Frame
Baseline through Week 52
Title
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Waist Circumference
Description
MS risk factor elevated waist circumference defined as ≥102 centimeters (cm) in men and ≥88 cm in women (Asian origin: ≥90 cm [men] and ≥80 cm [women]).
Time Frame
Baseline, Week 4, Week 12, Week 52
Title
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Systolic/Diastolic Blood Pressure
Description
MS risk factor elevated systolic/diastolic blood pressure defined as systolic blood pressure ≥130 millimeters of mercury (mm Hg) and/or diastolic blood pressure ≥85 mm Hg.
Time Frame
Baseline, Week 4, Week 12, Week 52
Title
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Fasting Glucose
Description
MS risk factor elevated fasting glucose defined as ≥5.6 millimoles per liter (mmol/L) (≥100 mg/dL).
Time Frame
Baseline, Week 4, Week 12, Week 52
Title
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Reduced High-density Lipoprotein Cholesterol (HDL-C)
Description
MS risk factor reduced HDL-C defined as <1.03 millimoles per liter (mmol/L) (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women.
Time Frame
Baseline, Week 4, Week 12, Week 52
Title
Change From Baseline in Individual Risk Factors of Metabolic Syndrome (MS): Elevated Triglycerides
Description
MS risk factor elevated triglycerides defined as ≥1.7 millimoles per liter (mmol/L) (1≥50 mg/dL).
Time Frame
Baseline, Week 4, Week 12, Week 52
Title
Change From Baseline in Ten-year Coronary Heart Disease (CHD) Risk According to Framingham Scoring System
Description
Framingham scoring system risk factors: age (risk points range: -9 to 16), cholesterol (risk points range: 0 to 13), HDL cholesterol (risk points range: -1 to 2), smoking (risk points range: 0 to 9), and systolic blood pressure (risk points range: 0 to 6); total risk points range <0 to ≥25, higher score indicates higher 10 year risk (range <1% to ≥30% 10 year risk).
Time Frame
Baseline, Week 4, Week 52
Title
Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels
Time Frame
Baseline, Week 52 or Early Termination
Title
Change From Baseline in Weight
Time Frame
Baseline, Week 4, Week 12, Week 52 or Early Termination
Title
Change From Baseline in Body Mass Index (BMI)
Description
Body mass index = weight in kilograms (kg) / height in meters (m)^2 .
Time Frame
Baseline, Week 4, Week 12, Week 52 or Early Termination
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame
Baseline, Week 52 or Early Termination
Title
Change From Baseline in Insulin Levels
Time Frame
Baseline, Week 52 or Early Termination
Title
Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF)
Description
QT interval is the time between the start of the Q wave and the end of the T wave in the cardiac electrical cycle. QTc is the QT interval corrected for heart rate. Corrected QT interval using Fridericia's heart rate correction formula: QTcF = QT/RR^1/3, where RR=RR interval in seconds.
Time Frame
Baseline, Week 4, Week 52 or Early Termination
Title
Change From Baseline in Apolipoprotein B (ApoB) Levels
Time Frame
Baseline, Week 52 or Early Termination
Title
Change From Baseline in Leptin
Time Frame
Baseline, Week 52 or Early Termination
Title
Change From Baseline in Physical Activity Index
Description
Physical activity (exercise) score derived for each participant based on the frequency and intensity of physical activities: regular walking, recreational activity, cycling, and sporting activity. Six categories of total score: inactive (range: 0-2), occasional (range: 3-5), light (range: 6-8), moderate (range: 9-12), moderately vigorous (range: 13-20), and vigorous (≥21). Higher score = higher frequency and intensity of physical activity.
Time Frame
Baseline, Week 28, Week 52 or Early Termination
Title
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) - Total Score
Description
Measures the overall severity of depressive symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms).
Time Frame
Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
Title
Change From Baseline in Young Mania Rating Scale (YMRS)
Description
11-item scale that measures the severity of manic episodes from subject reported symptoms over previous 48 hours and clinical observation during interview. Four items (irritability, speech, thought content, disruptive-aggressive behaviour) are rated on a scale from 0 (symptom not present) to 8 (symptom extremely severe). The remaining 7 items (elevated mood, increased motor activity-energy, sexual interest, sleep, language-thought disorder, appearance, insight) are rated on a scale from 0 (symptom not present) to 4 (symptom extremely severe). YMRS total score range = 0 to 60.
Time Frame
Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
Title
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Subscale
Description
CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected.
Time Frame
Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination
Title
Clinical Global Impression - Improvement (CGI-I) Subscale Score
Description
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time Frame
Week 52 or Early Termination
Title
Change From Baseline in Drug Attitude Inventory (DAI)
Description
DAI, a 10-item scale to assess how the attitude of schizophrenia participants toward their medications may affect compliance. Respondents indicate 'true' or 'false' for each item. An overall calculated score ranged from -10 to 10, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. Change: score at observation minus score at baseline.
Time Frame
Week 28, Week 52 or Early Termination
Title
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS)
Description
0-100 single score scale focusing exclusively on participant's level of social and occupational functioning; not directly influenced by overall severity of participant's psychological symptoms; higher score = higher level of functioning. 1 to 10 = persistent inability to maintain minimal personal hygiene; unable to function without harming self or others or without considerable external support; 91 to 100 = superior functioning in a wide range of activities.
Time Frame
Baseline, Week 28, Week 52 or Early Termination
Title
Change From Baseline in EuroQoL Index (EQ-I)
Description
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state (confined to bed). Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
Time Frame
Baseline, Week 28, Week 52 or Early Termination
Title
Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score
Description
EQ-5D: subject rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state.
Time Frame
Baseline, Week 28, Week 52 or Early Termination
Title
Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale
Description
31-item self report inventory to assess impact of weight on quality of life. Five subscales: physical functioning, self-esteem, sexual life, public distress, and work, with categories in each subscale scored 1 (no trouble or difficulty) to 5 (persistent trouble or difficulty). The rescaled IWQoL-Lite score is determined by the sum of scores on all 31 items and rescaling this sum to a 1 to 100 scoring with 0=the poorest and 100=the best quality of life.
Time Frame
Baseline, Week 28, Week 52 or Early Termination
Title
Number of Participants With Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment])
Description
C-SSRS is a participant rated questionnaire to assess suicidal ideation, suicidal behavior, actual attempts (yes or no responses), and intensity of ideation (rated 1=low severity to 5=high severity). Yes/No responses are mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) categories: Completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. A participant could have a yes or no response in more than one category.
Time Frame
Baseline, Week 1 through Week 52 or Early Termination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Foothills Medical Centre, Department of Psychiatry
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Mental Health Centre for Research and Education
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 2T9
Country
Canada
Facility Name
Dr. Alexander McIntyre Inc.
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 4M4
Country
Canada
Facility Name
Country Club Plaza
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3K 2E2
Country
Canada
Facility Name
Edgeland Medical, Dr. Alla Kirshner Medical Corporation
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3P 0N5
Country
Canada
Facility Name
Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2E2
Country
Canada
Facility Name
Office of Dr. A. K. Munshi
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1S 2E8
Country
Canada
Facility Name
Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1N 3V2
Country
Canada
Facility Name
Clinique St-Leonard
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1P 3K2
Country
Canada
Facility Name
Diex Research Sherbrooke Inc.
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 1Z1
Country
Canada
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1281190&StudyName=One-Year%20Trial%20of%20Oral%20Ziprasidone%20in%20Bipolar%20Patients%20with%20Metabolic%20Syndrome%20
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
We'll reach out to this number within 24 hrs