Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
ziprasidone, quetiapine (Seroquel) switch, open label, flexible dose, schizophrenia, schizoaffective disorder
Brief summary
The primary objective of this study is to evaluate change in weight as a result of switching from quetiapine to ziprasidone, in subjects with schizophrenia or schizoaffective disorder who have failed to achieve a satisfactory clinical response to quetiapine due to lack of efficacy or poor tolerability.
Interventions
DRUGziprasidone
Days 1-3: 40 mg twice a day (BID); Days 4-7: 60 mg BID; Day 8: 80 mg BID; Flexible dose between 40-80 mg BID (adjustable up to 40 mg daily/week) for the remainder of the 16-week treatment phase and continuing throughout the 16-week follow-up phase
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 55 Years
Healthy volunteers
No
Inclusion criteria
* Males or females, between 18 and 55 years of age, at the time of consent. * Subjects must have a primary diagnosis of schizophrenia, any subtype (code 295.xx), or schizoaffective disorder as defined in DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) * Subjects must have normal vital signs, physical examination, ECG, and laboratory findings except for minor deviations determined and documented to be clinically insignificant by the investigator or a sub-investigator who is a medical doctor.
Exclusion criteria
* Subjects who are unable to provide informed consent * Subjects who meet criteria for a DSM-IV-TR Axis I (Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition) diagnosis other than schizophrenia or schizoaffective disorder, including psychoactive substance abuse or dependence within one year of study entry * Females who are pregnant, breast feeding, or lactating at screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weight at Week 16 | Baseline, Week 16, Week 16 LOCF | Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 | Baseline, Week 16 | HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 | Baseline, Week 16 | HbAlc value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Fasting Glucose at Week 16 | Baseline, Week 16 | Fasting glucose value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Fasting Insulin at Week 16 | Baseline, Week 16 | Fasting insulin value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Waist and Hip Circumference at Week 16 | Baseline, Week 16 | Waist and hip circumference value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 | Baseline, Week 16 | AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline. |
| Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 | Baseline, Week 16 | Total cholesterol value: Change = value at Week 16 minus value at Baseline. |
| Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 | Baseline, Week 16, Week 16 LOCF | The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. |
| Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 | Week 16, Week 16 LOCF | The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse). |
| Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 | Baseline, Week 16, Week 16 LOCF | The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. |
| Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 | Baseline, Week 16, Week 16 LOCF | The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. |
| Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 | Baseline, Week 16, Week 16 LOCF | GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. |
| Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Baseline, Week 16, Week 16 LOCF | The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline. |
| Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Baseline, Week 16, Week 16 LOCF | PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline. |
Countries
Brazil, Germany, Greece, Spain, Turkey (Türkiye), United States
Participant flow
Pre-assignment details
An additional 14 subjects had a baseline visit but were never treated.
Participants by arm
| Arm | Count |
|---|---|
| Ziprasidone For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily. | 241 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 39 |
| Overall Study | Death | 1 |
| Overall Study | Laboratory Abnormality | 4 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Lost to Follow-up | 21 |
| Overall Study | Other | 33 |
| Overall Study | Withdrawal by Subject | 30 |
Baseline characteristics
| Characteristic | Ziprasidone |
|---|---|
| Age, Customized 18 to 44 years | 140 participants |
| Age, Customized < 18 years | 0 participants |
| Age, Customized 45 to 64 years | 101 participants |
| Age, Customized > = 65 years | 0 participants |
| Sex: Female, Male Female | 111 Participants |
| Sex: Female, Male Male | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 124 / 241 |
| serious Total, serious adverse events | 22 / 241 |
Outcome results
Primary
Change From Baseline in Weight at Week 16
Weight value: Change = value at Week 16 or Week 16 Last Observation Carried Forward (LOCF) minus value at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: Safety population = all enrolled subjects who took at least 1 dose of study medication. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Weight at Week 16 | Week 16 (n=133) | -1.09 kilogram | Standard Deviation 3.918 |
| Ziprasidone | Change From Baseline in Weight at Week 16 | Week 16 LOCF (n=231) | -0.73 kilogram | Standard Deviation 3.725 |
Comparison: Week 16.
Comparison: Week 16 LOCF. Based on past information, the standard deviation of the mean weight difference was expected to be 2.2. The sample size of the study was estimated so that the one-sided CI of the mean weight decrease has a certain width. To obtain a one-sided CI with a width of 0.27 kg, a sample size of 180 subjects was needed. In other words, we were 95% certain that the true mean weight decrease was in an interval starting from the observed weight decrease and extending 0.27 kg unit above it.
Secondary
Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16
AIMS: a 12-item clinician administered instrument assessing observed abnormal movements in different parts of body. Ten items scored on a 5-point scale (0 = none/normal, 4 = severe) evaluate abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42. Item 8 indicates severity, item 9 indicates Incapacitation. AIMS total, global severity, or global incapacitation score: Change = score at Week 16 minus score at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 | AIMS Total Score | 0.05 scores on a scale | Standard Deviation 2.251 |
| Ziprasidone | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 | AIMS Global Severity Score | 0.03 scores on a scale | Standard Deviation 0.472 |
| Ziprasidone | Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score, Global Severity Score, and Global Incapacitation Score at Week 16 | AIMS Global Incapacitation Score | 0.01 scores on a scale | Standard Deviation 0.383 |
Comparison: Total Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.32, 0.42]
Comparison: Global Severity Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.05, 0.11]
Comparison: Global Incapacitation Score. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.06, 0.07]
Secondary
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16
The CDSS is a 9-item, clinician-rated scale validated for rating the severity of depressive symptoms in subjects diagnosed with schizophrenia, and independent of confounding negative and extrapyramidal symptoms. The CDSS rates the severity of depressive symptoms on a 4-point scale ranging from 0 (absent) to 3 (severe). The CDSS depression total score is obtained by adding each of the item scores. Total possible score ranges from 0 to 27. CDSS possible total score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 | Week 16 (n=144) | -2.55 scores on a scale | Standard Deviation 4.364 |
| Ziprasidone | Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Week 16 | Week 16 LOCF (n=231) | -1.58 scores on a scale | Standard Deviation 4.526 |
Comparison: Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-3.27, -1.83]
Comparison: Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-2.16, -0.99]
Secondary
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16
The CGI-S is a single item, clinician-rated scale that assesses the global severity of the subject's overall illness. The CGI-S ratings range from 1 (normal, not at all ill) to 7 (among the most severely ill subjects). CGI-S score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 | Week 16 (n=135) | -0.76 scores on a scale | Standard Deviation 0.868 |
| Ziprasidone | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 16 | Week 16 LOCF (n=231) | -0.47 scores on a scale | Standard Deviation 0.848 |
Comparison: Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.9, -0.61]
Comparison: Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.58, -0.36]
Secondary
Change From Baseline in Fasting Glucose at Week 16
Fasting glucose value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in Fasting Glucose at Week 16 | 3.0 mg/dL | Standard Deviation 17.84 |
Comparison: The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.09, 6.15]
Secondary
Change From Baseline in Fasting Insulin at Week 16
Fasting insulin value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in Fasting Insulin at Week 16 | 134.8 microinternational (mciu)/milliliter(mL) | Standard Deviation 851.28 |
Comparison: The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-20.43, 289.98]
Secondary
Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16
Total cholesterol value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in Fasting Lipid Profile (Total Cholesterol) at Week 16 | -3.0 milligram (mg)/deciliter (dL) | Standard Deviation 31.14 |
Comparison: Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-8.48, 2.41]
Secondary
Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16
GAF Scale measures the severity of illness-related impairment in psychological, social, and occupational functioning using a 100-point scale. Total possible score ranges from 0 (not enough information available to provide GAF) to 100 (Superior functioning in a wide range of activities, life's problems never seem to get out of hand, is sought out by others because of his or her many qualities. No symptoms). The assessment was done by a trained assessor. GAF scale score: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 | Week 16 (n=145) | 7.88 scores on a scale | Standard Deviation 11.029 |
| Ziprasidone | Change From Baseline in Global Assessment of Function Scale (GAF) Score at Week 16 | Week 16 LOCF (n=230) | 5.27 scores on a scale | Standard Deviation 10.626 |
Comparison: Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [6.07, 9.69]
Comparison: Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [3.89, 6.65]
Secondary
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16
HbAlc value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ziprasidone | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 | 0.1 percent | Standard Deviation 0.44 |
Comparison: The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-0.02, 0.14]
Secondary
Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16
HDL, LDL, and triglyceride value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 | HDL (n=128) | -0.2 mg/dL | Standard Deviation 9.32 |
| Ziprasidone | Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 | LDL (n=123) | -2.5 mg/dL | Standard Deviation 25.66 |
| Ziprasidone | Change From Baseline in High-Density Lipoprotein (HDL), Low-Density Lipoprotein (LDL), and Triglycerides at Week 16 | Triglycerides (n=128) | -1.6 mg/dL | Standard Deviation 84.58 |
Comparison: HDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-1.82, 1.44]
Comparison: LDL. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-7.07, 2.09]
Comparison: Triglycerides. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-16.44, 13.15]
Secondary
Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16
PANSS measures severity of psychopathology in subjects with schizophrenia, schizoaffective disorder and other psychotic disorders. It includes 3 scales and a total of 30 items: 7 items comprise the positive scale, 7 comprise the negative scale, and 16 items measure general psychopathology. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210. PANSS total score and positive and negative scores: Change = score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: Intent-to-treat population (ITT) = all enrolled subjects with baseline and at least 1 post baseline efficacy evaluation. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Total Score, Week 16 (n=144) | -10.22 scores on a scale | Standard Deviation 15.027 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Total Score, Week 16 LOCF (n=231) | -6.61 scores on a scale | Standard Deviation 15.306 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Positive Subscale Score, Week 16 (n=144) | -3.30 scores on a scale | Standard Deviation 4.658 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Positive Subscale Score, Week 16 LOCF (n=231) | -2.43 scores on a scale | Standard Deviation 4.634 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Negative Subscale Score, Week 16 (n=144) | -1.67 scores on a scale | Standard Deviation 4.147 |
| Ziprasidone | Change From Baseline in Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score, and Positive and Negative Subscale Scores at Week 16 | Negative Subscale Score, Week 16 LOCF (n=231) | -0.92 scores on a scale | Standard Deviation 4.373 |
Comparison: Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-12.7, -7.75]
Comparison: Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-8.59, -4.63]
Comparison: Positive Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-4.07, -2.53]
Comparison: Positive Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-3.03, -1.83]
Comparison: Negative Subscale Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-2.36, -0.99]
Comparison: Negative Subscale Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-1.48, -0.35]
Secondary
Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16
The SCoRS is a 20-question rating scale completed via interviews with the subject and an informant, focusing on cognitive impairment and its impact on daily functioning. Each question was completed using a 4-point scale (ranging from 1=none to 4=severe). Total possible score ranged from 20 to 80. At the end of the 20 questions, the interviewer completed a Global Scale of 1-10, rating subject's overall difficulty. Higher scores on both indicated greater cognitive impairment. SCoRS total score and global rating: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 | Total Score, Week 16 (n=137) | -4.61 scores on a scale | Standard Deviation 7.981 |
| Ziprasidone | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 | Total Score, Week 16 LOCF (n=169) | -4.21 scores on a scale | Standard Deviation 8.961 |
| Ziprasidone | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 | Global Rating, Week 16 (n=137) | -1.02 scores on a scale | Standard Deviation 1.708 |
| Ziprasidone | Change From Baseline in Schizophrenia Cognition Rating Scale (SCoRS) Total Score and Global Rating at Week 16 | Global Rating, Week 16 LOCF (n=169) | -0.88 scores on a scale | Standard Deviation 1.643 |
Comparison: Total Score, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-5.95, -3.26]
Comparison: Total Score, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-5.57, -2.85]
Comparison: Global Rating, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-1.31, -0.73]
Comparison: Global Rating, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-1.13, -0.63]
Secondary
Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16
The TSQM is a 13-item subject-rated scale that evaluates the effectiveness, side effects and convenience of the medication over the past 2-3 weeks. Likert scale: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 0 and best value is 100. TSQM Effectivenss, Side Effect, Convenience, and Global Satisfaction scores: Change: score at Week 16 or Week 16 LOCF minus score at Baseline.
Time frame: Baseline, Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Global Satisfaction, Week 16 (n=179) | 15.32 scores on a scale | Standard Deviation 36.304 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Global Satisfaction, Week 16 LOCF (n=179) | 15.32 scores on a scale | Standard Deviation 36.304 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Effectiveness, Week 16 (n=178) | 10.49 scores on a scale | Standard Deviation 30.662 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Effectiveness, Week 16 LOCF (n=178) | 10.49 scores on a scale | Standard Deviation 30.662 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Side Effect, Week 16 (n=167) | 18.49 scores on a scale | Standard Deviation 42.883 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Side Effect, Week 16 LOCF (n=167) | 18.49 scores on a scale | Standard Deviation 42.883 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Convenience, Week 16 (n=180) | 6.45 scores on a scale | Standard Deviation 23.63 |
| Ziprasidone | Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TQSM) Effectiveness, Side Effect, Convenience, and Global Satisfaction Subscales at Week 16 | Convenience, Week 16 LOCF (n=180) | 6.45 scores on a scale | Standard Deviation 23.63 |
Comparison: Effectiveness, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [5.95, 15.02]
Comparison: Effectiveness, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [5.95, 15.02]
Comparison: Side Effect, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [11.94, 25.04]
Comparison: Side Effect, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [11.94, 25.04]
Comparison: Convenience, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [2.98, 9.93]
Comparison: Convenience, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [2.98, 9.93]
Comparison: Global Satisfaction, Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [9.97, 20.68]
Comparison: Global Satisfaction, Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [9.97, 20.68]
Secondary
Change From Baseline in Waist and Hip Circumference at Week 16
Waist and hip circumference value: Change = value at Week 16 minus value at Baseline.
Time frame: Baseline, Week 16
Population: Safety population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Change From Baseline in Waist and Hip Circumference at Week 16 | Waist (n=132) | -2.9 centimeter | Standard Deviation 17.53 |
| Ziprasidone | Change From Baseline in Waist and Hip Circumference at Week 16 | Hip (n=131) | -3.0 centimeter | Standard Deviation 18.21 |
Comparison: Waist. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-5.93, 0.11]
Comparison: Hip. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [-6.2, 0.1]
Secondary
Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16
The CGI-I is a 7-point, single-item, clinician-rated scale that assesses global improvement in the subject's clinical state in response to study treatment, and as compared to their status at pre-treatment baseline. Possible CGI-I scores range from 1 (very much improved) to 4 (no change) to 7 (very much worse).
Time frame: Week 16, Week 16 LOCF
Population: ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ziprasidone | Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 | Week 16 (n=135) | 2.7 scores on a scale | Standard Deviation 1.05 |
| Ziprasidone | Observed Cases of Clinical Global Impression Improvement Scale (CGI-I) Scores at Week 16 | Week 16 LOCF (n=231) | 3.2 scores on a scale | Standard Deviation 1.22 |
Comparison: Week 16. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [2.52, 2.88]
Comparison: Week 16 LOCF. The arithmetic mean and the corresponding 2-sided 95% CI are reported. All CIs are unadjusted for any multiplicity.95% CI: [3.02, 3.34]