| Primary | Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 | The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | The intent-to-treat (ITT) population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Day 56 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
| | | Title | Denominators | Categories |
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| Baseline | | | Title | Measurements |
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| - OG00089.6± 12.22
- OG00192.0± 12.09
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| | Change at Day 56 | | |
| | 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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| | ANCOVA | | 0.935 | Analysis of covariance (ANCOVA) model with treatment (paliperidone ER, aripiprazole) and country as factors, and baseline value as a covariate was used. | Least-squares (LS) mean difference | 0.1 | Standard Error of the Mean | 1.83 | 2-Sided | 95 | -3.46 | 3.76 | | | | No | Superiority or Other | | |
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| Secondary | Change From Baseline in PANSS Total Score at Day 182 | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline and Day 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 | The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Day 56 and Day 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Change From Baseline in Other Marder Factors Scores at Day 56 and 182 | The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Day 56 and 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 | The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a scale | | Baseline, Day 56 and 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Number of Participants With Clinical Stability | Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Number | | Participants | | Day 56 and 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 | The CGI-S rating scale is a 7-point global assessment that measures the Clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Median | Full Range | Units on a scale | | Baseline, Day 56 and 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 | The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Mean | Standard Deviation | Units on a Scale | | Baseline, Day 56 and Day 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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| Secondary | Number of Participants With PANSS Response | The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182. | The ITT population included all randomly assigned participants who received at least 1 dose of double-blind study drug, had both a Baseline measurement and at least 1 Post-Baseline measurement in the double-blind phase. Last observation carried forward (LOCF) method was used. | Posted | | Number | | Participants | | Day 56 and 182 | | | | ID | Title | Description |
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| OG000 | Paliperidone Extended Release (ER) | Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | | OG001 | Aripiprazole | Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
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