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Trial record 1 of 1 for:    NCT01113541
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One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT01113541
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : April 30, 2010
Results First Posted : July 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 28, 2010
First Posted Date  ICMJE April 30, 2010
Results First Submitted Date  ICMJE October 12, 2011
Results First Posted Date  ICMJE July 9, 2012
Last Update Posted Date July 9, 2012
Study Start Date  ICMJE July 2010
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
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 [ Time Frame: Week 52 or Early Termination ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
Percentage of subjects achieving a reduction from baseline of at least 1 risk factor for metabolic syndrome at endpoint (end of week 52 visit or upon premature discontinuation if prior to end of Week 52 Visit) [ Time Frame: 1 year ]
Change History Complete list of historical versions of study NCT01113541 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 5, 2012)
  • Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) [ Time Frame: Baseline, Week 52 ]
    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 [ Time Frame: Baseline through Week 52 ]
    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 [ Time Frame: Baseline through Week 52 ]
    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 [ Time Frame: Baseline through Week 52 ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]
    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) [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 52 ]
    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 [ Time Frame: Baseline, Week 4, Week 52 ]
    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 [ Time Frame: Baseline, Week 52 or Early Termination ]
  • Change From Baseline in Weight [ Time Frame: Baseline, Week 4, Week 12, Week 52 or Early Termination ]
  • Change From Baseline in Body Mass Index (BMI) [ Time Frame: Baseline, Week 4, Week 12, Week 52 or Early Termination ]
    Body mass index = weight in kilograms (kg) / height in meters (m)^2 .
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Week 52 or Early Termination ]
  • Change From Baseline in Insulin Levels [ Time Frame: Baseline, Week 52 or Early Termination ]
  • Change From Baseline in Corrected QT Interval (QTc): Fridericia's Heart Rate Correction Formula (QTcF) [ Time Frame: Baseline, Week 4, Week 52 or Early Termination ]
    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 [ Time Frame: Baseline, Week 52 or Early Termination ]
  • Change From Baseline in Leptin [ Time Frame: Baseline, Week 52 or Early Termination ]
  • Change From Baseline in Physical Activity Index [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]
    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) [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]
    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 [ Time Frame: Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination ]
    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 [ Time Frame: Week 52 or Early Termination ]
    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) [ Time Frame: Week 28, Week 52 or Early Termination ]
    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) [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]
    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) [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]
    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 [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]
    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 [ Time Frame: Baseline, Week 28, Week 52 or Early Termination ]
    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]) [ Time Frame: Baseline, Week 1 through Week 52 or Early Termination ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 28, 2010)
  • Mean change from baseline in the number of risk factors of MS [ Time Frame: 1 year ]
  • Metabolic Syndrome rate (MS prevalence) [ Time Frame: 1 year ]
  • Changes in the proportion of subjects with each individual MS risk factors (shift table from baseline) [ Time Frame: 1 year ]
  • Individual MS risk factors: Waist circumference, triglycerides, HDL-Cholesterol, systolic/ diastolic blood pressure, fasting glucose [ Time Frame: 1 year ]
  • Changes from baseline in individual risk factors of MS: waist circumferences, systolic/diastolic blood pressure, triglycerides, HDL-Cholesterol, fasting glucose [ Time Frame: 1 year ]
  • Change from baseline in Ten-year CHD risk according to Framingham scoring system [ Time Frame: 1 year ]
  • Changes from baseline in Total cholesterol and LDL-cholesterol levels [ Time Frame: 1 year ]
  • Changes from baseline in weight and BMI [ Time Frame: 1 year ]
  • Changes from baseline in HbA1c and insulin level [ Time Frame: 1 year ]
  • Change from baseline in corrected QT interval (QTc) [ Time Frame: 1 year ]
  • Changes from baseline in Leptin and ApoB level [ Time Frame: 1 year ]
  • Change from baseline in the Physical Activity Index [ Time Frame: 1 year ]
  • Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 1 year ]
  • Change from baseline in the Young Mania Rating Scale (YMRS) [ Time Frame: 1 year ]
  • Change from baseline in Clinical Global Impression-Severity subscale (CGI-S) [ Time Frame: 1 year ]
  • Clinical Global Impression-Improvement subscale scores at endpoint (CGI-I) [ Time Frame: 1 year ]
  • Change from baseline in Drug-Attitude Inventory - 30-item version (DAI-30) [ Time Frame: 1 year ]
  • Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) [ Time Frame: 1 year ]
  • Changes from baseline in EuroQoL Index (EQ-I) and Visual Analog Scale (VAS) [ Time Frame: 1 year ]
  • Change From Baseline in Impact of Weight on Quality of Life-Lite Version (IWQOL-Lite) Scale [ Time Frame: 1 year ]
  • Incidence of Suicidal Tendencies (Columbian-Suicide Severity Rating Scale, [C-SSRS], Mapped to C-CASA [Columbia Classification Algorithm For Suicide Assessment]) [ Time Frame: 1 year ]
  • Incidence of adverse events (AEs) and discontinuations from the study [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bipolar Disorder
Intervention  ICMJE Drug: Ziprasidone HCL (oral)
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
Other Name: Zeldox, Geodon
Study Arms  ICMJE Experimental: Active treatment (switch to oral Ziprasidone)
Intervention: Drug: Ziprasidone HCL (oral)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 3, 2011)
13
Original Estimated Enrollment  ICMJE
 (submitted: April 28, 2010)
155
Actual Study Completion Date  ICMJE February 2011
Actual Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01113541
Other Study ID Numbers  ICMJE A1281190
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP