| Primary | Baseline Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score | The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening. | The Intent-to-Treat population included all randomized participants who received at least 1 dose of study medication (or any portion of a dose) and had both baseline and at least 1 postbaseline PANSS assessment. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00091.6± 12.5
- OG00195.9± 13.0
- OG00292.7± 12.6
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| Secondary | Number of Participants With Response | Response is defined as a 30% or more reduction from baseline in PANSS total score and a CGI-C score of <= 2. (CGI-C-SCA: Clinical Global Impression of Change for Schizoaffective Disorder). The PANSS is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. 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 subject. | Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group. | Posted | | Number | | count of participants | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Subscale Score | Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. Higher scores indicate worsening. | Intent-to-Treat population. | Posted | | Mean | Standard Deviation | points on subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Subscale Score | Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) General Psychopathology Subscale Score | General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Positive and Negative Symptoms of Schizophrenia (PANSS) Positive Factor Score | Positive PANSS Factor Score (range 8-56): Sum of scores for items 1, 3, 5, and 6 in positive subscale: delusions, hallucinatory behavior, grandiosity, suspiciousness; item 7 in negative subscale: stereotyped thinking; and items 1, 9, and 12 in general psychopathology subscale: somatic concern, unusual thought content, lack of judgment, and insight. Higher scores indicate worsening. | Intent-to-Treat population. | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Other Pre-specified | Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 | Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63. | Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Other Pre-specified | Change in Hamilton Rating Scale for Depression (HAM-D-21) With Baseline HAM-D-21 Total Score >= 16 | Clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. The items are rated on either a 5-point (0 to 4) or a 3-point (0 to 2) scale. The 5-point scale uses a rating of 0 (absent), 1 (doubtful to mild), 2 (mild to moderate), 3 (moderate to severe), and 4 (very severe). Higher scores indicate worsening. The responses are summed to yield the HAM-D-21 score that ranges from 0-63. | Intent-to-Treat population with a baseline HAM-D-21 total score of >= 16. | Posted | | Mean | Standard Deviation | points on scale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Negative Factor Score | Negative PANSS Factor Score (range 7-49): Sum of scores for items 1, 2, 3, 4, and 6 in negative subscale: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity; and items 7 and 16 in general psychopathology subscale: motor retardation, and active social avoidance. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Disorganized Thought Factor Score | Disorganized Thoughts PANSS Factor Score (range 7-49): Sum of scores for item 2 in positive subscale:Conceptual disorganization; item 5 in negative subscale:difficulty in abstract thinking; and items 5, 10, 11, 13, and 15 in general psychopathology subscale: mannerisms/posturing, disorientation, poor attention, disturbance of volition, and preoccupation. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Uncontrolled Hostility/Excitement Factor Score | Uncontrolled Hostility/Excitement PANSS Factor Score (range 4-28): Sum of scores for items 4 and 7 in positive subscale: excitement, hostility; and items 8 and 14 in general psychopathology subscale: uncooperativeness, and poor impulse control. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Positive and Negative Symptoms of Schizophrenia (PANSS) Anxiety/Depression Factor Score | Anxiety/Depression PANSS Factor Score (range 4-28): Sum of scores for items 2, 3, 4, and 6 in general psychopathology subscale: Anxiety, Guilt feelings, Tension, Depression. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on a subscale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder Score at Baseline | 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 subject. 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 subjects". | Intent-to-Treat population. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Change in Clinical Global Impression (CGI-S) - Severity for Schizoaffective Disorder | 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 subject. 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 subjects". | Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group. | Posted | | Mean | Standard Deviation | points on scale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Primary | The Change From Baseline to Week 6 or the Last Post-randomization Assessment During Double-blind Treatment in the Positive and Negative Symptoms of Schizophrenia (PANSS) Total Score. | The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening. | Intent-to-Treat population | Posted | | Mean | Standard Deviation | points on scale | | Baseline to Week 6 Last Observation Carried Forward (LOCF) End Point | | | | ID | Title | Description |
|---|
| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Secondary | Clinical Global Impression (CGI-C) - Change for Schizoaffective Disorder | The CGI-C rating scale is a 7 point global assessment that measures the clinician's impression of the change occurring in the illness over a course of treatment, relative to baseline. A rating of 4 is equivalent to "No change". Ratings of <4 are equivalent to "improvement" and ratings of > 4 are equivalent to "worsening". | Intent-to-Treat population. One patient was not evaluable in the Paliperidone ER Low Dose treatment group. | Posted | | Mean | Standard Deviation | points on a scale | | Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Other Pre-specified | Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 | 11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60. | Intent-to-Treat population with a baseline YMRS total score of >= 16. | Posted | | Mean | Standard Deviation | points on a scale | | Baseline | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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| Other Pre-specified | Change in Young Mania Rating Scale (YMRS) With Baseline YMRS Total Score >= 16 | 11-item scale (elevated mood, increased motor activity, sexual interest, sleep, irritability, speech [rate/amount], language-thought disorder, content, disruptive-aggressive behaviors, appearance, and insight) based on subject's report of his or her condition and clinician's behavioral observations during the interview, with emphasis on the latter. Higher scores indicate worsening. The responses are summed to yield the YMRS total score, which ranges from 0 to 60. | Intent-to-Treat population with a baseline YMRS total score of >= 16. | Posted | | Mean | Standard Deviation | points on scale | | Baseline to Week 6 LOCF End Point | | | | ID | Title | Description |
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| OG000 | Placebo | | | OG001 | Paliperidone Extended Release (ER) Low Dose | Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day | | OG002 | Paliperidone Extended Release (ER) High Dose | Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day |
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