Schizophrenia and Disorders With Psychotic Features
Conditions
Keywords
Ziprasidone, metabolic syndrome, risk factors, schizophrenia, psychotic disorders.
Brief summary
The purpose of this study is to explore the impact of ziprasidone on the distribution of metabolic syndrome risk factors in a population of patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.
Detailed description
The trial was terminated prematurely on May 24, 2012, due to changes in organizational strategy and resources. The decision to terminate the trial was not based on any safety or efficacy concerns.
Interventions
Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40 to 160 mg total daily dose) for up to 1 year.
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS) | Endpoint (premature discontinuation or Week 52) | MS risks factors: elevated (el) waist, men:\>=102 centimeters(cm), women:\>=88 cm (Asian origin:\>=90 cm in men, \>=80 cm in women); el triglycerides: \>=1.7 millimoles per liter (mmol/L) (\>=150 milligram per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C), men:\<1.03 mmol/L (\<40 mg/dL), women:\<1.3 mmol/L (\<50 mg/dL); el fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP\>=130 millimeters of mercury (mmHg) and/or DBP\>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 3 or more of 5 characteristics: abdominal obesity, hypertriglyceridemia, low high-density lipoprotein (HDL) cholesterol, high blood pressure, and high fasting glucose. |
| Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline, Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Waist circumference data is reported separately for male and female participants. |
| Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles). |
| Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants. |
| Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | — |
| Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 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 CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from \<1% to \>=30%, where higher percent indicates greater risk for CHD. |
| Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | — |
| Change From Baseline in Weight at Week 4,12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | — |
| Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)\^2 . |
| Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | MS risks factors: elevated waist circumference: greater than or equal to (\>=)102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (\<)1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg. |
| Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | — |
| Change From Baseline in the Physical Activity Index Score at Week 28 and 52 | Baseline, Week 28, 52 | 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 total score = higher frequency and intensity of physical activity. |
| Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | 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 (60 divided by heart rate). |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Baseline, Week 12, 28, 52 | Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity. |
| Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Baseline, Week 12, 28, 52 | CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants). |
| Clinical Global Impression-Improvement (CGI-I) Scale Score | Endpoint (premature discontinuation or Week 52) | CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse. |
| Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 | Baseline, Week 28, 52 | DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance. |
| Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 | Baseline, Week 28, 52 | SOFAS: a 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. |
| Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 | Baseline, Week 28, 52 | EQ-5D: participant 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. |
| Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 | Baseline, Week 28, 52 | EQ-5D: participant 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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. |
| Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52 | Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52 | C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior(3)(Yes on preparatory acts or behavior), suicidal ideation(4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(Yes on Has subject engaged in non-suicidal self-injurious behavior). |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Baseline, Week 4, 12, 28, 52 | HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ziprasidone Ziprasidone 40 mg capsule orally twice daily from Day 1 to 3, followed by ziprasidone 60 mg capsule orally twice daily from Day 4 to 7, then ziprasidone 80 mg capsule orally twice daily from Day 8 to 15 and thereafter ziprasidone 20 to 80 mg capsule orally twice daily as per investigator's discretion from Day 16 to 365. | 172 |
| Total | 172 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 49 |
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 12 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Other | 9 |
| Overall Study | Protocol Violation | 13 |
| Overall Study | Study terminated by sponsor | 5 |
| Overall Study | Withdrawal by Subject | 22 |
Baseline characteristics
| Characteristic | Ziprasidone |
|---|---|
| Age, Continuous | 37.9 years STANDARD_DEVIATION 12.2 |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 122 / 172 |
| serious Total, serious adverse events | 20 / 172 |
Outcome results
Primary
Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS)
MS risks factors: elevated (el) waist, men:\>=102 centimeters(cm), women:\>=88 cm (Asian origin:\>=90 cm in men, \>=80 cm in women); el triglycerides: \>=1.7 millimoles per liter (mmol/L) (\>=150 milligram per deciliter \[mg/dL\]); reduced high-density lipoprotein cholesterol (HDL-C), men:\<1.03 mmol/L (\<40 mg/dL), women:\<1.3 mmol/L (\<50 mg/dL); el fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); el systolic/diastolic blood pressure (SBP/DBP): SBP\>=130 millimeters of mercury (mmHg) and/or DBP\>=85 mmHg. Responder=at least 1 less risk factor at endpoint (premature discontinuation or Week 52) than baseline.
Time frame: Endpoint (premature discontinuation or Week 52)
Population: Per protocol (PP) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure, and remained in the study for at least 16 weeks. Missing values were imputed using last observation carried forward (LOCF).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ziprasidone | Percentage of Participants Achieving at Least 1 Risk Factor Reduction From Baseline for Metabolic Syndrome (MS) | 58.77 percentage of participants |
Secondary
Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 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 CHD risk. The risk points are transformed to 10-year risk percentage for CHD which ranges from \<1% to \>=30%, where higher percent indicates greater risk for CHD.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Baseline (n=113) | 9.3 percent of 10-year CHD risk | Standard Deviation 5.9 |
| Ziprasidone | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Change at Week 4 (n=112) | -0.7 percent of 10-year CHD risk | Standard Deviation 2.5 |
| Ziprasidone | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Change at Week 12 (n=111) | -0.9 percent of 10-year CHD risk | Standard Deviation 2.1 |
| Ziprasidone | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Change at Week 28 (n=97) | -1.2 percent of 10-year CHD risk | Standard Deviation 2.3 |
| Ziprasidone | Change From Baseline in 10-year Cardiovascular Heart Disease (CHD) Risk According to Framingham Scoring System at Week 4, 12, 28 and 52 | Change at Week 52 (n=113) | -1.3 percent of 10-year CHD risk | Standard Deviation 2.4 |
Secondary
Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52
Body mass index calculated as weight in kilograms (kg) divided by height in (meters) squared (m)\^2 .
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Baseline (n=114) | 32.4 kg/m^2 | Standard Deviation 4.3 |
| Ziprasidone | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Change at Week 4 (n=113) | -0.3 kg/m^2 | Standard Deviation 1.2 |
| Ziprasidone | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Change at Week 12 (n=112) | -0.8 kg/m^2 | Standard Deviation 1.6 |
| Ziprasidone | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Change at Week 28 (n=100) | -1.2 kg/m^2 | Standard Deviation 2.3 |
| Ziprasidone | Change From Baseline in Body Mass Index (BMI) at Week 4, 12, 28 and 52 | Change at Week 52 (n=114) | -1.5 kg/m^2 | Standard Deviation 2.8 |
Secondary
Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52
CGI-S is a single-item, clinician-rated scale that assesses the global severity of the participants overall illness. CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill participants).
Time frame: Baseline, Week 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Baseline (n=113) | 3.3 units on a scale | Standard Deviation 0.9 |
| Ziprasidone | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Change at Week 12 (n=112) | -0.3 units on a scale | Standard Deviation 0.7 |
| Ziprasidone | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Change at Week 28 (n=100) | -0.2 units on a scale | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) Score at Week 12, 28 and 52 | Change at Week 52 (n=113) | -0.2 units on a scale | Standard Deviation 1.1 |
Secondary
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
C-SSRS assessed whether participant experienced following: completed suicide(1), suicide attempt(2) (response of Yes on actual attempt), preparatory acts toward imminent suicidal behavior(3)(Yes on preparatory acts or behavior), suicidal ideation(4) (Yes on wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with methods without intent to act/some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior(7)(Yes on Has subject engaged in non-suicidal self-injurious behavior).
Time frame: Baseline, Week 1, 2, 4, 8, 12, 20, 28, 36, 44 and 52
Population: Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
Secondary
Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52
DAI, a 30-item scale measuring subjective responses to medication (including acceptability and tolerability which aims to understand the factors influencing treatment adherence). Scale has 15 items (statements) scored as true and 15 items scored as false. An overall calculated score ranged from -15 to 15, where a positive score indicated a positive subjective response (compliant), a negative score indicated non-compliance.
Time frame: Baseline, Week 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 | Baseline (n=105) | -1.3 units on a scale | Standard Deviation 5.8 |
| Ziprasidone | Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 | Change at Week 28 (n=104) | 0.4 units on a scale | Standard Deviation 6.5 |
| Ziprasidone | Change From Baseline in Drug-Attitude Inventory-30-Item Scale (DAI-30) Score at Week 28 and 52 | Change at Week 52 (n=105) | -0.1 units on a scale | Standard Deviation 6.1 |
Secondary
Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52
EQ-5D: participant 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, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 | Baseline | 0.8 units on a scale | Standard Deviation 0.3 |
| Ziprasidone | Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 | Change at Week 28 | 0.0 units on a scale | Standard Deviation 0.2 |
| Ziprasidone | Change From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Index (EQ-I) Score at Week 28 and 52 | Change at Week 52 | 0.0 units on a scale | Standard Deviation 0.2 |
Secondary
Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Baseline (n=114) | 104.5 mg/dL | Standard Deviation 25.7 |
| Ziprasidone | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Change at Week 4 (n=113) | -0.8 mg/dL | Standard Deviation 19.7 |
| Ziprasidone | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Change at Week 12 (n=112) | -4.0 mg/dL | Standard Deviation 20.3 |
| Ziprasidone | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Change at Week 28 (n=99) | -5.0 mg/dL | Standard Deviation 19.1 |
| Ziprasidone | Change From Baseline in Fasting Glucose Level at Week 4, 12, 28 and 52 | Change at Week 52 (n=114) | -3.0 mg/dL | Standard Deviation 31 |
Secondary
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Baseline (n=114) | 5.7 percentage of total hemoglobin | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Change at Week 4 (n=111) | -0.0 percentage of total hemoglobin | Standard Deviation 0.2 |
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Change at Week 12 (n=112) | -0.0 percentage of total hemoglobin | Standard Deviation 0.3 |
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Change at Week 28 (n=99) | -0.1 percentage of total hemoglobin | Standard Deviation 0.4 |
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Concentration at Week 4, 12, 28 and 52 | Change at Week 52 (n=114) | -0.1 percentage of total hemoglobin | Standard Deviation 0.4 |
Secondary
Change From Baseline in Insulin Level at Week 4, 12, 28 and 52
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values were imputed using LOCF at Week 52. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Baseline (n=107) | 22.4 international unit per liter (IU/L) | Standard Deviation 27.1 |
| Ziprasidone | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Change at Week 4 (n=102) | -0.3 international unit per liter (IU/L) | Standard Deviation 28.9 |
| Ziprasidone | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Change at Week 12 (n=104) | -4.6 international unit per liter (IU/L) | Standard Deviation 20.9 |
| Ziprasidone | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Change at Week 28 (n=92) | -7.8 international unit per liter (IU/L) | Standard Deviation 23.5 |
| Ziprasidone | Change From Baseline in Insulin Level at Week 4, 12, 28 and 52 | Change at Week 52 (n=107) | -5.6 international unit per liter (IU/L) | Standard Deviation 31 |
Secondary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52
Assesses positive and negative symptoms, general psychopathology specifically associated with schizophrenia. Scale consists of 30 items, each rated on scale from 1 (symptom not present) - 7 (symptoms extremely severe). Sum of 30 items is defined as PANSS total score, range:30-210. 7 items make up positive scale (delusions, conceptual disorganization, hallucinatory behavior); total range: 7-49. 7 items make up negative scale (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal); total range: 7-49. For each subscale, total score: higher score=greater severity.
Time frame: Baseline, Week 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Baseline: Total Score (n=112) | 64.1 units on a scale | Standard Deviation 17.8 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Baseline: Positive Subscale Score (n=113) | 13.6 units on a scale | Standard Deviation 4.6 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Baseline: Negative Subscale Score (n=112) | 17.9 units on a scale | Standard Deviation 6.6 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 12: Total Score (n=110) | -5.7 units on a scale | Standard Deviation 11.6 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 12: Positive Subscale Score (n=112) | -1.0 units on a scale | Standard Deviation 3.2 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 12: Negative Subscale Score (n=111) | -1.9 units on a scale | Standard Deviation 4.5 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 28: Total Score (n=98) | -4.4 units on a scale | Standard Deviation 14.3 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 28: Positive Subscale Score (n=100) | -0.9 units on a scale | Standard Deviation 4.5 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 28: Negative Subscale Score (n=98) | -1.6 units on a scale | Standard Deviation 5.3 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 52: Total Score (n=112) | -3.2 units on a scale | Standard Deviation 17 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 52: Positive Subscale Score (n=113) | -0.2 units on a scale | Standard Deviation 5.6 |
| Ziprasidone | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score, Positive and Negative Subscale Scores at Week 12, 28 and 52 | Change at Week 52: Negative Subscale Score (n=112) | -1.7 units on a scale | Standard Deviation 5.5 |
Secondary
Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52
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 (60 divided by heart rate).
Time frame: Baseline, Week 4, 12, 28, 52
Population: Intent-to-treat (ITT) population included all enrolled participants who received at least 1 dose of study medication, had baseline and at least 1 post-baseline MS measure. Missing values at Week 52 were imputed using LOCF. N (number of participants analyzed)=participants evaluable for this measure. n=evaluable participants at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Baseline (n=56) | 413.2 milliseconds | Standard Deviation 24.1 |
| Ziprasidone | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Change at Week 4 (n=4) | 0.9 milliseconds | Standard Deviation 22 |
| Ziprasidone | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Change at Week 12 (n=14) | 3.4 milliseconds | Standard Deviation 27.7 |
| Ziprasidone | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Change at Week 28 (n=38) | 6.6 milliseconds | Standard Deviation 23.7 |
| Ziprasidone | Change From Baseline in QT Interval Corrected for Heart Rate (QTc) at Week 4, 12, 28 and 52 | Change at Week 52 (n=56) | 7.6 milliseconds | Standard Deviation 22.8 |
Secondary
Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52
SOFAS: a 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.
Time frame: Baseline, Week 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 | Baseline | 57.2 units on a scale | Standard Deviation 11.5 |
| Ziprasidone | Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 | Change at Week 28 | 1.6 units on a scale | Standard Deviation 11.3 |
| Ziprasidone | Change From Baseline in Social and Occupational Functioning Assessment Scale (SOFAS) Score at Week 28 and 52 | Change at Week 52 | 1.1 units on a scale | Standard Deviation 11.4 |
Secondary
Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52
BP measurement is recorded as systolic BP (SBP, BP when heart is contracting; it is the maximum arterial pressure during contraction of left ventricle) and diastolic BP (DBP, BP when heart is relaxing; it is the minimum arterial pressure during relaxation and dilation of ventricles).
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Baseline: SBP (n=114) | 124.3 mmHg | Standard Deviation 13.3 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Baseline: DBP (n=114) | 80.7 mmHg | Standard Deviation 9.5 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 4: SBP (n=113) | -1.0 mmHg | Standard Deviation 10 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 4: DBP (n=113) | -0.4 mmHg | Standard Deviation 7.6 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 12: SBP (n=112) | -1.0 mmHg | Standard Deviation 11.8 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 12: DBP (n=112) | -0.1 mmHg | Standard Deviation 8 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 28: SBP (n=100) | -1.0 mmHg | Standard Deviation 11.9 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 28: DBP (n=100) | 0.0 mmHg | Standard Deviation 9.5 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 52: SBP (n=114) | -1.0 mmHg | Standard Deviation 11.2 |
| Ziprasidone | Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at Week 4, 12, 28 and 52 | Change at Week 52: DBP (n=114) | -1.1 mmHg | Standard Deviation 8.8 |
Secondary
Change From Baseline in the Physical Activity Index Score at Week 28 and 52
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 total score = higher frequency and intensity of physical activity.
Time frame: Baseline, Week 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in the Physical Activity Index Score at Week 28 and 52 | Baseline | 7.3 units on a scale | Standard Deviation 6.8 |
| Ziprasidone | Change From Baseline in the Physical Activity Index Score at Week 28 and 52 | Change at Week 28 | 0.6 units on a scale | Standard Deviation 6.5 |
| Ziprasidone | Change From Baseline in the Physical Activity Index Score at Week 28 and 52 | Change at Week 52 | 0.5 units on a scale | Standard Deviation 6.3 |
Secondary
Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Baseline: TC (n=114) | 5.5 mmol/L | Standard Deviation 1.1 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Baseline: LDL-C (n=114) | 3.3 mmol/L | Standard Deviation 1.1 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 4: TC (n=113) | -0.3 mmol/L | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 4: LDL-C (n=110) | -0.1 mmol/L | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 12: TC (n=112) | -0.4 mmol/L | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 12: LDL-C (n=112) | -0.2 mmol/L | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 28: TC (n=99) | -0.4 mmol/L | Standard Deviation 0.8 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 28: LDL-C (n=97) | -0.2 mmol/L | Standard Deviation 0.7 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 52: TC (n=114) | -0.5 mmol/L | Standard Deviation 0.7 |
| Ziprasidone | Change From Baseline in Total Cholesterol (TC) and Low Density Lipoprotein-Cholesterol (LDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 52: LDL-C (n=114) | -0.3 mmol/L | Standard Deviation 0.8 |
Secondary
Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52
Triglyceride data is reported for whole study population whereas HDL-C data is reported separately for male and female participants.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline: Triglyceride (n=114) | 242.8 mg/dL | Standard Deviation 115.1 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline: HDL-C, Male (n=79) | 35.8 mg/dL | Standard Deviation 7.2 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Baseline: HDL-C, Female (n=35) | 41.9 mg/dL | Standard Deviation 9 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 4: Triglyceride (n=111) | -37.3 mg/dL | Standard Deviation 103.8 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 4: HDL-C, Male (n=78) | 1.2 mg/dL | Standard Deviation 5.1 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 4: HDL-C, Female (n=35) | 2.1 mg/dL | Standard Deviation 7.8 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 12: Triglyceride (n=112) | -39.5 mg/dL | Standard Deviation 93.9 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 12: HDL-C, Male (n=77) | 2.1 mg/dL | Standard Deviation 6 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 12: HDL-C, Female (n=35) | 1.8 mg/dL | Standard Deviation 5.8 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 28: Triglyceride (n=99) | -52.3 mg/dL | Standard Deviation 103.8 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 28: HDL-C, Male (n=69) | 3.1 mg/dL | Standard Deviation 5.4 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 28: HDL-C, Female (n=30) | 4.5 mg/dL | Standard Deviation 8 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 52: Triglyceride (n=114) | -60.0 mg/dL | Standard Deviation 100.7 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 52: HDL-C, Male (n=79) | 3.9 mg/dL | Standard Deviation 7 |
| Ziprasidone | Change From Baseline in Triglyceride and High Density Lipoprotein-Cholesterol (HDL-C) Levels at Week 4, 12, 28 and 52 | Change at Week 52: HDL-C, Female (n=35) | 5.0 mg/dL | Standard Deviation 8.8 |
Secondary
Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52
Waist circumference data is reported separately for male and female participants.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Baseline: Male (n=79) | 110.8 cm | Standard Deviation 10 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Baseline: Female (n=35) | 108.9 cm | Standard Deviation 10.5 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 4: Male (n=78) | -1.0 cm | Standard Deviation 3.1 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 4: Female (n=35) | 0.4 cm | Standard Deviation 3 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 12: Male (n=77) | -2.1 cm | Standard Deviation 4.9 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 12: Female (n=35) | -2.4 cm | Standard Deviation 6.8 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 28: Male (n=70) | -3.7 cm | Standard Deviation 7.2 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 28: Female (n=30) | -2.5 cm | Standard Deviation 5.8 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 52: Male (n=79) | -3.6 cm | Standard Deviation 7.5 |
| Ziprasidone | Change From Baseline in Waist Circumference at Week 4, 12, 28 and 52 | Change at Week 52: Female (n=35) | -4.0 cm | Standard Deviation 8.9 |
Secondary
Change From Baseline in Weight at Week 4,12, 28 and 52
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Weight at Week 4,12, 28 and 52 | Baseline (n=114) | 96.5 kilogram (kg) | Standard Deviation 16.9 |
| Ziprasidone | Change From Baseline in Weight at Week 4,12, 28 and 52 | Change at Week 4 (n=113) | -0.9 kilogram (kg) | Standard Deviation 3.9 |
| Ziprasidone | Change From Baseline in Weight at Week 4,12, 28 and 52 | Change at Week 12 (n=112) | -2.4 kilogram (kg) | Standard Deviation 5.1 |
| Ziprasidone | Change From Baseline in Weight at Week 4,12, 28 and 52 | Change at Week 28 (n=100) | -3.8 kilogram (kg) | Standard Deviation 7.4 |
| Ziprasidone | Change From Baseline in Weight at Week 4,12, 28 and 52 | Change at Week 52 (n=114) | -4.4 kilogram (kg) | Standard Deviation 8.4 |
Secondary
Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52
EQ-5D: participant 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 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
Time frame: Baseline, Week 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 | Baseline (n=112) | 58.8 units on a scale | Standard Deviation 27.4 |
| Ziprasidone | Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 | Change at Week 28 (n=111) | 4.7 units on a scale | Standard Deviation 30.5 |
| Ziprasidone | Changes From Baseline in European Quality of Life (EuroQoL) - 5 Dimensions Visual Analog Scale (VAS) Score at Week 28 and 52 | Change at Week 52 (n=112) | 5.7 units on a scale | Standard Deviation 30.4 |
Secondary
Clinical Global Impression-Improvement (CGI-I) Scale Score
CGI-I is a single-item, clinician-rated scale that assesses global improvement in the participants clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 to 7, where 1=very much improved, 4=no change and 7=very much worse.
Time frame: Endpoint (premature discontinuation or Week 52)
Population: PP population. Missing values at Week 52 were imputed using LOCF. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Clinical Global Impression-Improvement (CGI-I) Scale Score | 3.2 units on a scale | Standard Deviation 1.4 |
Secondary
Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52
MS risks factors: elevated waist circumference: greater than or equal to (\>=)102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): less than (\<)1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Baseline (n=114) | 3.4 risk factors | Standard Deviation 1 |
| Ziprasidone | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Change at Week 4 (n=113) | -0.3 risk factors | Standard Deviation 1 |
| Ziprasidone | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Change at Week 12 (n=112) | -0.4 risk factors | Standard Deviation 1.1 |
| Ziprasidone | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Change at Week 28 (n=98) | -0.7 risk factors | Standard Deviation 1.3 |
| Ziprasidone | Mean Change From Baseline in the Number of Risk Factors of Metabolic Syndrome (MS) at Week 4, 12, 28 and 52 | Change at Week 52 (n=114) | -0.8 risk factors | Standard Deviation 1.2 |
Secondary
Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52
MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg.
Time frame: Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4: Decrease by at least 1 risk factor (n=113) | 46 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4: No change in risk factor (n=113) | 46 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 4: Increase by at least 1 risk factor (n=113) | 21 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 12:Decrease by at least 1 risk factor (n=112) | 44 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 12: No change in risk factor (n=112) | 51 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 12:Increase by at least 1 risk factor (n=112) | 17 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 28: Decrease by at least 1 risk factor (n=98) | 45 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 28: No change in risk factor (n=98) | 39 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 28: Increase by at least 1 risk factor (n=98) | 14 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 52:Decrease by at least 1 risk factor (n=114) | 67 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 52: No change in risk factor (n=114) | 35 participants |
| Ziprasidone | Number of Participants With Change From Baseline in Metabolic Syndrome (MS) Risk Factors at Week 4, 12, 28 and 52 | Week 52:Increase by at least 1 risk factor (n=114) | 12 participants |
Secondary
Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS)
MS risks factors: elevated waist circumference: \>=102 cm in men, \>=88 cm in women (Asian origin: \>=90 cm \[men\], \>=80 cm \[women\]); elevated triglycerides: \>=1.7 mmol/L (\>=150 mg/dL); reduced high-density lipoprotein cholesterol (HDL-C): \<1.03 mmol/L (\<40 mg/dL) in men, \<1.3 mmol/L (\<50 mg/dL) in women; elevated fasting glucose: \>=5.6 mmol/L (\>=100 mg/dL); elevated SBP/DBP: SBP \>=130 mmHg and/or DBP \>=85 mmHg.
Time frame: Baseline, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Elevated waist circumference (n=114) | 93.86 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Elevated triglycerides (n=114) | 83.33 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Reduced HDL-C (n=114) | 78.07 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Elevated SBP (n=114) | 32.46 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Elevated DBP (n=114) | 26.32 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Baseline: Elevated fasting glucose (n=114) | 44.74 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Elevated waist circumference (n=113) | 88.50 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Elevated triglycerides (n=111) | 60.36 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Reduced HDL-C (n=113) | 71.68 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Elevated SBP (n=113) | 31.86 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Elevated DBP (n=113) | 29.20 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 4: Elevated fasting glucose (n=113) | 46.02 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Elevated waist circumference (n=112) | 83.93 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Elevated triglycerides (n=112) | 61.61 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Reduced HDL-C (n=112) | 72.32 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Elevated SBP (n=112) | 29.46 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Elevated DBP (n=112) | 31.25 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 12: Elevated fasting glucose (n=112) | 36.61 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Elevated waist circumference (n=100) | 76.00 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Elevated triglycerides (n=99) | 56.57 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Reduced HDL-C (n=99) | 61.62 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Elevated SBP (n=100) | 29.00 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Elevated DBP (n=100) | 35.00 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 28: Elevated fasting glucose (n=99) | 37.37 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Elevated waist circumference (n=114) | 72.81 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Elevated triglycerides (n=114) | 52.63 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Reduced HDL-C (n=114) | 63.16 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Elevated SBP (n=114) | 28.95 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Elevated DBP (n=114) | 28.95 percentage of participants |
| Ziprasidone | Percentage of Participants With Individual Risk Factors of Metabolic Syndrome (MS) | Week 52: Elevated fasting glucose (n=114) | 32.46 percentage of participants |
Secondary
Percentage of Participants With Metabolic Syndrome (MS)
According to the National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATPIII), metabolic syndrome is defined as a condition that includes 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, Week 4, 12, 28, 52
Population: PP population. Missing values at Week 52 were imputed using LOCF. n=participants evaluable for this measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Ziprasidone | Percentage of Participants With Metabolic Syndrome (MS) | Baseline (n=114) | 79.82 percentage of participants |
| Ziprasidone | Percentage of Participants With Metabolic Syndrome (MS) | Week 4 (n=113) | 70.80 percentage of participants |
| Ziprasidone | Percentage of Participants With Metabolic Syndrome (MS) | Week 12 (n=112) | 72.32 percentage of participants |
| Ziprasidone | Percentage of Participants With Metabolic Syndrome (MS) | Week 28 (n=98) | 58.16 percentage of participants |
| Ziprasidone | Percentage of Participants With Metabolic Syndrome (MS) | Week 52 (n=114) | 52.63 percentage of participants |