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See termination reason in detailed description.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active treatment (switch to oral Ziprasidone) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone HCL (oral) | Drug | Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 or Early Termination |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre, Department of Psychiatry | Calgary | Alberta | T2N 2T9 | Canada | ||
| Mental Health Centre for Research and Education |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Twenty-seven participants were screened for the study and 13 participants were assigned to study drug and treated.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ziprasidone | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ziprasidone | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Per protocol population: all subjects in the intent-to-treat population who remained in the study for at least 28 weeks. N = number of participants with analyzable data at observation. | Posted | Number | percentage of participants | Week 52 or Early Termination |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ziprasidone | Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA (14.0) | Non-systematic Assessment |
This study was terminated due to slow enrollment and changes in organizational strategy and resources; most of the planned analyses in the statistical analysis plan were not performed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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|
| Baseline, Week 52 |
| 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. | Baseline through Week 52 |
| 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. | Baseline through Week 52 |
| 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. | Baseline through Week 52 |
| 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]). | Baseline, Week 4, Week 12, Week 52 |
| 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. | Baseline, Week 4, Week 12, Week 52 |
| 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). | Baseline, Week 4, Week 12, Week 52 |
| 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. | Baseline, Week 4, Week 12, Week 52 |
| 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). | Baseline, Week 4, Week 12, Week 52 |
| 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). | Baseline, Week 4, Week 52 |
| Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels | Baseline, Week 52 or Early Termination |
| Change From Baseline in Weight | Baseline, Week 4, Week 12, Week 52 or Early Termination |
| Change From Baseline in Body Mass Index (BMI) | Body mass index = weight in kilograms (kg) / height in meters (m)^2 . | Baseline, Week 4, Week 12, Week 52 or Early Termination |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, Week 52 or Early Termination |
| Change From Baseline in Insulin Levels | Baseline, Week 52 or Early Termination |
| 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. | Baseline, Week 4, Week 52 or Early Termination |
| Change From Baseline in Apolipoprotein B (ApoB) Levels | Baseline, Week 52 or Early Termination |
| Change From Baseline in Leptin | Baseline, Week 52 or Early Termination |
| 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. | Baseline, Week 28, Week 52 or Early Termination |
| 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). | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
| 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. | Week 52 or Early Termination |
| 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. | Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 28, Week 52 or Early Termination |
| 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. | Baseline, Week 1 through Week 52 or Early Termination |
| Calgary |
| Alberta |
| T2N 2T9 |
| Canada |
| Dr. Alexander McIntyre Inc. | Penticton | British Columbia | V2A 4M4 | Canada |
| Country Club Plaza | Winnipeg | Manitoba | R3K 2E2 | Canada |
| Edgeland Medical, Dr. Alla Kirshner Medical Corporation | Winnipeg | Manitoba | R3P 0N5 | Canada |
| Capital, Health Authority, QE II Health Sciences Centre, Mood Disorder Clinic | Halifax | Nova Scotia | B3H 2E2 | Canada |
| Office of Dr. A. K. Munshi | Sydney | Nova Scotia | B1S 2E8 | Canada |
| Centre de recherche Fernand-Seguin de l'hopital Louis H. Lafontaine | Montreal | Quebec | H1N 3V2 | Canada |
| Clinique St-Leonard | Montreal | Quebec | H1P 3K2 | Canada |
| Diex Research Sherbrooke Inc. | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Adverse Event |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ziprasidone |
Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing. |
|
|
| Secondary | 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. | PP and Intent-to-treat (ITT) population; ITT population = all participants enrolled in the study who received at least 1 dose of study medication and who had baseline and at least 1 post-baseline MS measurement. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 52 |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline through Week 52 |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline through Week 52 |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline through Week 52 |
|
|
| Secondary | 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]). | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 |
|
|
| Secondary | 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). | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 |
|
|
| Secondary | 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). | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 |
|
|
| Secondary | 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). | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 52 |
|
|
| Secondary | Change From Baseline in Total Cholesterol and Low-density Lipoprotein (LDL) Cholesterol Levels | PP and ITT. Median was reported due to small sample size and risk of skewing. | Posted | Median | Full Range | milligrams per deciliter | Baseline, Week 52 or Early Termination |
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| Secondary | Change From Baseline in Weight | PP and ITT; n = number of participants with evaluable data at observation. | Posted | Mean | Standard Deviation | kilograms | Baseline, Week 4, Week 12, Week 52 or Early Termination |
|
|
|
| Secondary | Change From Baseline in Body Mass Index (BMI) | Body mass index = weight in kilograms (kg) / height in meters (m)^2 . | PP and ITT. Results for BMI not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 52 or Early Termination |
|
|
| Secondary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | PP and ITT. Median was reported due to small sample size and risk of skewing. Last observation = last observation while on study drug or during the lag. | Posted | Median | Full Range | percent HbA1c | Baseline, Week 52 or Early Termination |
|
|
|
| Secondary | Change From Baseline in Insulin Levels | PP and ITT. Insulin levels not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT; n = number of participants with analyzable data at observation. | Posted | Mean | Standard Deviation | milliseconds | Baseline, Week 4, Week 52 or Early Termination |
|
|
|
| Secondary | Change From Baseline in Apolipoprotein B (ApoB) Levels | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 52 or Early Termination |
|
|
| Secondary | Change From Baseline in Leptin | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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). | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
|
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| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 4, Week 12, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 28, Week 52 or Early Termination |
|
|
| Secondary | 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. | PP and ITT. Results not reported: data not summarized due to limited enrollment and early termination of the study. | Posted | Baseline, Week 1 through Week 52 or Early Termination |
|
|
| 1 |
| 13 |
| 13 |
| 13 |
| Constipation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Upper respiratory infection | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Blood prolactin increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| High density lipoprotein decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Low density lipoprotein increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA (14.0) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Memory impairment | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Sedation | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Emotional disorder | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Flat affect | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Hypomania | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Mania | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Terminal insomnia | Psychiatric disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| Title | Measurements |
|---|---|
|
| LDL cholesterol: Change at Last Observation |
|
|
| Value at Week 52 (n=10) |
|
| Title | Measurements |
|---|---|
|