| 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. | 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. | Posted | | Mean | Standard Deviation | kilogram | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
| | | Title | Denominators | Categories |
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| Week 16 (n=133) | | | | Week 16 LOCF (n=231) | | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | | | | | One-sided upper confidence limit | -0.53 | | | 1-Sided | 95 | | | | | A one-sided 95% confidence interval (CI) was constructed for the mean weight change from baseline to infer whether there was a significant decrease in weight. | | Superiority or Other (legacy) | | | | |
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| 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. | | Posted | | Mean | Standard Deviation | milligram (mg)/deciliter (dL) | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 16 | HbAlc value: Change = value at Week 16 minus value at Baseline. | | Posted | | Mean | Standard Deviation | percent | | Baseline, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| Secondary | Change From Baseline in Fasting Glucose at Week 16 | Fasting glucose value: Change = value at Week 16 minus value at Baseline. | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| Secondary | Change From Baseline in Fasting Insulin at Week 16 | Fasting insulin value: Change = value at Week 16 minus value at Baseline. | | Posted | | Mean | Standard Deviation | microinternational (mciu)/milliliter(mL) | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | centimeter | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16 | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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). | ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Week 16, Week 16 LOCF | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | ITT. LOCF was used to impute missing values. LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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| 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. | ITT. LOCF was used to impute missing values. The LOCF value was the last non-missing, post-baseline observation carried forward for each subject. | Posted | | Mean | Standard Deviation | scores on a scale | | Baseline, Week 16, Week 16 LOCF | | | | ID | Title | Description |
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| OG000 | 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. |
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