Schizophrenia
Conditions
Keywords
Schizophrenia, Paliperidone
Brief summary
The purpose of this study is to evaluate effectiveness, tolerability (how well a participant can stand a particular medicine or treatment), and safety of flexible-dose of paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), previously taking risperidone (an antipsychotic), but who are not satisfied with their treatment.
Detailed description
This is an open-label (a medical research study in which participants and researchers are told which treatments the participants are receiving, unblinded), multi-center (when more than 1 hospital or medical school team work on a medical research study), non-randomized, single-arm study of paliperidone ER in participants previously treated with risperidone with poor response. The study will consist of 2 phases: a main phase of 6 months and an extension phase of another 6 months. The total duration of the study will be 12 months. All participants will receive an oral (having to do with the mouth) daily dose of paliperidone ER in flexible dosage (in the range of 3-12 milligram \[mg\]: 3 mg, 6 mg, 9 mg, or 12 mg) according to Investigator's discretion. Efficacy and safety of participants will primarily be evaluated by Positive and Negative Syndrome Scale (PANSS) and Extrapyramidal Symptoms Rating Scale (ESRS), respectively. Participants' safety will be monitored throughout the study.
Interventions
Paliperidone ER tablets in the flexible dose ranging from 3 to 12 mg will be administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion.
Sponsors
Janssen-Cilag Farmaceutica Ltda.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female participants must be postmenopausal (after the time in life when a woman stops having a menstrual period) or surgically sterile or if sexually active, practicing an effective method of birth control (e.g., oral contraceptive, intrauterine device \[IUD - an intrauterine device made of plastic and/or copper that is inserted into the womb \[uterus\] by way of the vaginal canal to used to prevent pregnancy\], diaphragm with spermicide \[agent that kills spermatozoa\] or condom \[cover worn over the penis during sexual intercourse to prevent infection or pregnancy\] with spermicide) throughout the study and have a negative serum beta - Human Chorionic Gonadotropin (HCG) pregnancy test at screening * Participants on oral monotherapy (treatment with a single drug) with risperidone in a regimen within the daily dosage recommended by the package insert and adhering to the prescribed risperidone regimen for at least 30 days before entering the study * Participants with partial response to the current risperidone regimen (persistent symptoms or unstable clinical condition) or presence of unbearable side effects * Potential Participants switching to another atypical antipsychotic due to their clinical response and/or side effects profile.
Exclusion criteria
* Participants with past or current history of psychiatric disease other than schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV * Participants with concomitant (given at the same time) severe (very serious, life threatening) medical or neurological disorder or risk of suicide * Participants previously using clozapine * Participants with a history of previous non-responsiveness to oral antipsychotic treatment * Pregnant or breast-feeding female participants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase | Baseline and Week 52 | 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. |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase | Baseline and Week 26 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase | Week 52 | Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. 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. |
| Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Baseline, Week 4, 8, 13 and 26 | The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven 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). |
| Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline, Week 4, 8, 13, 26, 39 and 52 | The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven 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). |
| Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase | Baseline, Week 4, 8, 13 and 26 | The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. |
| Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline, Week 4, 8, 13, 26, 39 and 52 | The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function. |
| Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Baseline, Week 4, 8, 13 and 26 | The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality. |
| Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline, Week 4, 8, 13 and 26 | 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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening. |
| Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39 and 52 | 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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening. |
| Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline, Week 4, 8, 13 and 26 | Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad. |
| Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline, Week 4, 8, 13, 26, 39 and 52 | Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad. |
| 36-Item Short-Form Health Survey (SF-36) Score - Main Phase | Baseline and Week 26 | The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning. |
| 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase | Baseline and Week 52 | The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning. |
| Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline, Week 4, 8, 13, 26, 39 and 52 | The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality. |
| Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase | Week 26 | Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Baseline, Week 4, 8, 13 and 26 | An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. |
| Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline, Week 4, 8, 13, 26, 39 and 52 | An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paliperidone ER - Main Phase Plus Extension Phase Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator's discretion. | 218 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Extension Phase | Other | 3 |
| In-Between Main Phase & Extension Phase | Extension phase was optional | 15 |
| Main Phase | Adverse Event | 7 |
| Main Phase | Did not received study medication | 5 |
| Main Phase | Inform consent withdrawal | 1 |
| Main Phase | Lack of Efficacy | 8 |
| Main Phase | Lost to Follow-up | 6 |
| Main Phase | Non-compliance to study medication | 5 |
| Main Phase | Other | 1 |
| Main Phase | Selection failure | 2 |
| Main Phase | Withdrawal by Subject | 14 |
Baseline characteristics
| Characteristic | Paliperidone ER - Main Phase Plus Extension Phase |
|---|---|
| Age Continuous | 37.87 Years STANDARD_DEVIATION 11.01 |
| Age, Customized 18-21 years | 14 Participants |
| Age, Customized 22-29 years | 50 Participants |
| Age, Customized 30-39 years | 51 Participants |
| Age, Customized 40-49 years | 67 Participants |
| Age, Customized 50-60 years | 35 Participants |
| Age, Customized 61-69 years | 1 Participants |
| Personal and Social Performance (PSP) Scale Score | 44.39 Units on a scale STANDARD_DEVIATION 13.11 |
| Pittsburg Sleep Quality Index (PSQI) | 6.7 Units on a scale STANDARD_DEVIATION 4.1 |
| Positive and Negative PANSS Subscales Score Negative PANSS Subscale Score | 19.76 Units on a scale STANDARD_DEVIATION 5.79 |
| Positive and Negative PANSS Subscales Score Positive PANSS Subscale Score | 27.37 Units on a scale STANDARD_DEVIATION 6.48 |
| Positive and Negative Syndrome Scale (PANSS) Total Score | 94.49 Units on a scale STANDARD_DEVIATION 12.38 |
| Race/Ethnicity, Customized Black | 52 Participants |
| Race/Ethnicity, Customized Brown | 34 Participants |
| Race/Ethnicity, Customized Mulatto | 9 Participants |
| Race/Ethnicity, Customized Oriental | 3 Participants |
| Race/Ethnicity, Customized White/Caucasian | 120 Participants |
| Sex: Female, Male Female | 79 Participants |
| Sex: Female, Male Male | 139 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 144 / 215 | 70 / 159 |
| serious Total, serious adverse events | 14 / 215 | 3 / 159 |
Outcome results
Primary
Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase
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.
Time frame: Baseline and Week 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase | Baseline | 93.25 Units on a scale | Standard Deviation 11.6 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PANSS Total Score at Week 52 - Main Phase Plus Extension Phase | Change at Week 52 | -26.4 Units on a scale | Standard Deviation 17.5 |
Primary
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase
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.
Time frame: Baseline and Week 26
Population: The intent-to-treat for effectiveness (ITTe) population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Last Observation Carried Forward (LOCF) method was used.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 - Main Phase | -22.9 Units on a scale | Standard Deviation 20.1 |
Secondary
36-Item Short-Form Health Survey (SF-36) Score - Main Phase
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time frame: Baseline and Week 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase | Baseline: Physical component summary | 47.9 Units on a scale | Standard Deviation 8.8 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase | Baseline: Mental component summary | 35.9 Units on a scale | Standard Deviation 8.5 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase | Week 26: Physical component summary | 48.4 Units on a scale | Standard Deviation 7.6 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase | Week 26: Mental component summary | 38.3 Units on a scale | Standard Deviation 8 |
Secondary
36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase
The SF-36 is designed to assess the health status of participants. The SF-36 includes 1 multi-item scale measuring physical health component and mental health component. Physical health component includes physical functioning, role limitations due to physical health, pain and general health. Mental health component includes role limitations due to emotional problems, energy/fatigue, emotional well being and social functioning. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state. The score for a component (physical or mental) is an average of the individual item scores. Each component is scored on a scale of 1 to 100, where 100=highest level of functioning.
Time frame: Baseline and Week 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase | Baseline: Physical component summary | 48.7 Units on a scale | Standard Deviation 8.6 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase | Baseline: Mental component summary | 35.7 Units on a scale | Standard Deviation 8.5 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase | Week 52: Physical component summary | 48.8 Units on a scale | Standard Deviation 7.6 |
| Paliperidone Extended Release (ER) - Main Phase | 36-Item Short-Form Health Survey (SF-36) Score - Main Phase Plus Extension Phase | Week 52: Mental component summary | 38.5 Units on a scale | Standard Deviation 8.4 |
Secondary
Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 4 (n=201) | 5.7 Units on a scale | Standard Deviation 11.7 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 8 (n=191) | 8.3 Units on a scale | Standard Deviation 12.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 13 (n=182) | 9.9 Units on a scale | Standard Deviation 14.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Personal and Social Performance (PSP) Scale Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 26 (n=204) | 10.4 Units on a scale | Standard Deviation 14.9 |
Secondary
Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Baseline (n=198) | 6.7 Units on a scale | Standard Deviation 4.1 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 4 (n=174) | -1.0 Units on a scale | Standard Deviation 3.5 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 8 (n=162) | -1.2 Units on a scale | Standard Deviation 3.5 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 13 (n=156) | -1.5 Units on a scale | Standard Deviation 3.3 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Pittsburg Sleep Quality Index (PSQI) Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 26 (n=174) | -1.4 Units on a scale | Standard Deviation 3.7 |
Secondary
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PANSS Positive Subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS Negative Subscale assesses seven 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).
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline: PANSS positive subscale (n=159) | 26.65 Units on a scale | Standard Deviation 6.2 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline: PANSS negative subscale (n=159) | 19.25 Units on a scale | Standard Deviation 5.86 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 4: PANSS positive subscale (n=159) | -3.4 Units on a scale | Standard Deviation 4.4 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 4: PANSS negative subscale (n=159) | -3.4 Units on a scale | Standard Deviation 4.4 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 8: PANSS positive subscale (n=159) | -5.4 Units on a scale | Standard Deviation 5.1 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 8: PANSS negative subscale (n=159) | -5.4 Units on a scale | Standard Deviation 5.1 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 13: PANSS positive subscale (n=159) | -5.9 Units on a scale | Standard Deviation 5.7 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 13: PANSS negative subscale (n=159) | -5.9 Units on a scale | Standard Deviation 5.7 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 26: PANSS positive subscale (n=159) | -6.8 Units on a scale | Standard Deviation 5.5 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 26: PANSS negative subscale (n=159) | -6.8 Units on a scale | Standard Deviation 5.5 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 39: PANSS positive subcale (n=152) | -7.3 Units on a scale | Standard Deviation 5.9 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 39: PANSS negative subscale (n=152) | -7.3 Units on a scale | Standard Deviation 5.9 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 52: PANSS positive subscale (n=154) | -7.5 Units on a scale | Standard Deviation 6.1 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 52: PANSS negative subscale (n=154) | -7.5 Units on a scale | Standard Deviation 6.1 |
Secondary
Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase
The PANSS positive subscale assesses 7 positive-symptoms of schizophrenia. Positive symptoms refer to an excess or distortion of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology). The PANSS negative subscale assesses seven 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).
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 4: PANSS positive subscale (n=201) | -3.6 Units on a scale | Standard Deviation 4.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 4: PANSS negative subscale (n=201) | -3.6 Units on a scale | Standard Deviation 4.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 8: PANSS positive subscale (n=191) | -5.0 Units on a scale | Standard Deviation 5.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 8: PANSS negative subscale (n=191) | -5.0 Units on a scale | Standard Deviation 5.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 13: PANSS positive subscale (n=182) | -5.9 Units on a scale | Standard Deviation 5.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 13: PANSS negative subscale (n=182) | -5.9 Units on a scale | Standard Deviation 5.8 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 26: PANSS positive subscale (n=203) | -5.9 Units on a scale | Standard Deviation 6.2 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Positive and Negative PANSS Subscales Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 26: PANSS negative subscale (n=203) | -5.9 Units on a scale | Standard Deviation 6.2 |
Secondary
Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PSP scale evaluates the dysfunction degree exhibited by the participants, regarding 4 behavioral domains: useful social activities, personal and social relations, self-care and agitated and aggressive behavior. Each domain were assessed on a 6-point scale (0=absent to 5=very severe). A transformed score from 1 to 100 is generated from the raw score based on the clinical interpretation of the scores generated in the 4 areas of functioning, with a higher transformed score indicating better function.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline (n=159) | 45.17 Units on a scale | Standard Deviation 12.84 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 4 (n=159) | 5.3 Units on a scale | Standard Deviation 9.6 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 8 (n=159) | 9.0 Units on a scale | Standard Deviation 12.6 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 13 (n=159) | 9.7 Units on a scale | Standard Deviation 14.4 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 26 (n=159) | 12.0 Units on a scale | Standard Deviation 12.7 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 39 (n=151) | 12.6 Units on a scale | Standard Deviation 14.2 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in PSP Scale Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 52 (n=155) | 14.6 Units on a scale | Standard Deviation 14.9 |
Secondary
Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
The PSQI evaluates sleep behavior by means of 7 components: sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disorders, use of sleep medication and daytime dysfunction. The sum of the 7 component scores produces a global score of subjective sleep quality that varies from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline (n=148) | 6.4 Units on a scale | Standard Deviation 4.1 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 4 (n=140) | -1.0 Units on a scale | Standard Deviation 3.6 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 8 (n=136) | -1.3 Units on a scale | Standard Deviation 3.2 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 13 (137) | -1.5 Units on a scale | Standard Deviation 3.2 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 26 (n=135) | -1.4 Units on a scale | Standard Deviation 3.5 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 39 (n=133) | -1.9 Units on a scale | Standard Deviation 3.9 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline PSQI Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 52 (n=133) | -1.9 Units on a scale | Standard Deviation 3.4 |
Secondary
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening.
Time frame: Week 39 and 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Normal without any disease (n=152) | 2 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Borderline (n=152) | 22 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Slightly ill (n=152) | 41 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Moderately ill (n=152) | 55 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Markedely ill (n=152) | 22 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 39: Severely ill (n=152) | 10 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 52: Borderline (n=155) | 23 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 52: Slightly ill (n=155) | 37 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 52: Moderately ill (n=155) | 58 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 52: Markedely ill (n=155) | 24 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Extension Phase | Week 52: Severely ill (n=155) | 10 Participants |
Secondary
Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase
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.The categories included in the scale are normal, without any disease, borderline, slightly ill, moderately ill, markedly ill, severely ill and extremely ill. A rating of 1=Normal, not at all ill and a rating of 7 =Among the most extremely ill participants. Higher scores indicate worsening.
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Borderline (n=213) | 2 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Slightly ill (n=213) | 4 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Moderately ill (n=213) | 52 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Markedly ill (n=213) | 114 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Severely ill (n=213) | 40 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Baseline: Extremely ill (n=213) | 1 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 4: Borderline (n=201) | 4 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 4: Slightly ill (n=201) | 25 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 4: Moderately ill (n=201) | 87 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 4: Markedly ill (n=201) | 61 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 4: Severely ill (n=201) | 24 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: Borderline (n=191) | 5 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: Slightly ill (n=191) | 35 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: Moderately ill (n=191) | 80 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: Markedly ill (n=191) | 56 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: Severely ill (n=191) | 15 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 8: extremely ill (n=191) | 0 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Normal, without any disease (n=182) | 2 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Borderline (n=182) | 7 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Slightly ill (n=182) | 41 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Moderately ill (n=182) | 73 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Markedly ill (n=182) | 47 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 13: Severly ill (n=182) | 12 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Normal without any disease (n=204) | 3 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Borderline (n=204) | 16 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Slightly ill (n=204) | 48 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Moderately ill (n=204) | 70 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Markedely ill (n=204) | 48 Participants |
| Paliperidone Extended Release (ER) - Main Phase | Number of Participants With Clinical Global Impression-Severity (CGI-S) Score - Main Phase | Week 26: Severely ill (n=204) | 19 Participants |
Secondary
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. 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.
Time frame: Week 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase | 60.1 Percentage of participants |
Secondary
Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase
Participants with response in PANSS total score was defined as participants with greater than or equal to 20 percent reduction in PANSS total score from Baseline. 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.
Time frame: Week 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. LOCF method was used.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Response in PANSS Total Score - Main Phase Plus Extension Phase | 71.1 Percentage of participants |
Secondary
Percentage of Participants With Treatment Satisfaction - Main Phase
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. Here 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline: Very good (n=213) | 11.7 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline: Good (n=213) | 38.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline: Moderate (n=213) | 34.3 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline: Bad (n=213) | 12.7 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Baseline: Very bad (n=213) | 2.8 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 4: Very good (n=200) | 29.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 4: Good (n=200) | 52.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 4: Moderate (n=200) | 16.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 4: Bad (n=200) | 1.0 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 4: Very bad (n=200) | 0.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 8: Very good (n=190) | 33.7 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 8: Good (n=190) | 48.9 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 8: Moderate (n=190) | 13.7 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 8: Bad (n=190) | 3.7 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 13: Very good (n=182) | 37.4 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 13: Good (n=182) | 46.2 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 13: Moderate (n=182) | 12.1 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 13: Bad (n=182) | 3.8 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 13: Very bad (n=182) | 0.5 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 26: Very good (n=204) | 36.3 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 26: Good (n=204) | 46.1 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 26: Moderate (n=204) | 10.8 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 26: Bad (n=204) | 4.4 Percentage of Participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction - Main Phase | Week 26: Very bad (n=204) | 2.5 Percentage of Participants |
Secondary
Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase
Participant's response regarding satisfaction with the treatment were recorded. A 5-point evaluation scale was used to evaluate participant satisfaction: very good, good, moderate, bad and very bad.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
Population: The ITTe population included all the participants who received at least 1 dose of study medication and provided at least 1 post-baseline effectiveness measurement. 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 39: Very bad (n=152) | 0.7 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline: Very good (n=159) | 13.2 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline: Good (n=159) | 40.9 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline: Moderate (n=159) | 32.1 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline: Bad (n=159) | 11.3 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Baseline: Very bad (n=159) | 2.5 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 4: Very good (n=159) | 31.4 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 4: Good (n=159) | 54.1 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 4: Moderate (n=159) | 13.8 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 4: Very bad (n=159) | 0.6 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 8: Very good (n=159) | 37.1 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 8: Moderate (n=159) | 11.3 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 8: Bad (n=159) | 3.1 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 13: Very good (n=159) | 39.0 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 13: Good (n=159) | 46.5 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 13: Moderate (n=159) | 10.1 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 13: Bad (n=159) | 3.8 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 13: Very bad (n=159) | 0.6 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 26: Very good (n=159) | 41.5 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 26: Good (n=159) | 50.9 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 26: Moderate (n=159) | 6.9 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 26: Very bad (n=159) | 0.6 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 39: Very good (n=152) | 38.8 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 39: Good (n=152) | 51.3 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 39: Moderate (n=152) | 7.2 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 39: Bad (n=152) | 2.0 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 52: Very good (n=155) | 41.3 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 52: Good (n=155) | 43.2 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 52: Moderate (n=155) | 12.9 Percentage of participants |
| Paliperidone Extended Release (ER) - Main Phase | Percentage of Participants With Treatment Satisfaction-Main Phase Plus Extension Phase | Week 52: Bad (n=155) | 2.6 Percentage of participants |
Other Pre-specified
Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase
An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time frame: Baseline, Week 4, 8, 13, 26, 39 and 52
Population: The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Baseline (n=159) | 1.41 Units on a scale | Standard Deviation 2.14 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 4 (n=159) | -0.51 Units on a scale | Standard Deviation 1.31 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 8 (n=159) | -0.49 Units on a scale | Standard Deviation 1.56 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 13 (n=159) | -0.68 Units on a scale | Standard Deviation 1.85 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 26 (n=158) | -0.77 Units on a scale | Standard Deviation 1.87 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 39 (n=151) | -0.81 Units on a scale | Standard Deviation 1.97 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in ESRS Total Score at Week 4, 8, 13, 26, 39 and 52 - Main Phase Plus Extension Phase | Change at Week 52 (n=154) | -0.75 Units on a scale | Standard Deviation 1.94 |
Other Pre-specified
Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase
An ESRS scale is used to assess the extrapyramidal symptoms attributable to antipsychotics. It consists of 8 items to assess individual symptoms and each item is assessed from 0 (none, normal) to 4 (severe). The total score is the sum of the 8 item scores, for a total range of 0 (normal) to 32 (severe). The items for the assessment of individual symptoms are classified into 4 categories of parkinsonism, akathisia, dystonia and dyskinesia.
Time frame: Baseline, Week 4, 8, 13 and 26
Population: The safety analysis population included all the participants that received at least one dose of study medication and provided any post-baseline information. Here 'N' specifies those participants who were evaluated for this outcome measure and 'n' specifies those participants who were evaluated for this outcome measure at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Baseline (n=215) | 1.30 Units on a scale | Standard Deviation 1.99 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 4 (n=201) | -0.40 Units on a scale | Standard Deviation 1.23 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 8 (n=189) | -0.45 Units on a scale | Standard Deviation 1.47 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 13 (n=182) | -0.63 Units on a scale | Standard Deviation 1.76 |
| Paliperidone Extended Release (ER) - Main Phase | Change From Baseline in Extrapyradimal Symptoms Rating Scale (ESRS) Total Score at Week 4, 8, 13 and 26 - Main Phase | Change at Week 26 (n=201) | -0.6 Units on a scale | Standard Deviation 1.71 |