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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4011 | Other Identifier | Janssen-Cilag Farmaceutica Ltda. |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Experimental | Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone Extended Release (ER) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Week 26 |
| 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. | Baseline and Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belo Horizonte | Brazil | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24289141 | Derived | Gattaz WF, Campos JA, Lacerda AL, Henna E, Ruschel SI, Bressan RA, de Oliveira IR, Rocha FL, Grabowski HM, Sacomani E Jr, Louza MR, Quevedo J, Elkis H, Zorzetto Filho D, Perico Cde A, Lawson FL, Appolinario JC. Switching from oral risperidone to flexibly dosed oral paliperidone extended-release: core symptoms, satisfaction, and quality of life in patients with stable but symptomatic schizophrenia: the RISPALI study. Curr Med Res Opin. 2014 Apr;30(4):695-709. doi: 10.1185/03007995.2013.869201. Epub 2013 Dec 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Phase |
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| Week 26 |
| 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. | Week 52 |
| 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). | Baseline, Week 4, 8, 13 and 26 |
| 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). | Baseline, Week 4, 8, 13, 26, 39 and 52 |
| 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. | Baseline, Week 4, 8, 13 and 26 |
| 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. | Baseline, Week 4, 8, 13, 26, 39 and 52 |
| 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. | Baseline, Week 4, 8, 13 and 26 |
| 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. | Baseline, Week 4, 8, 13, 26, 39 and 52 |
| 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. | Baseline, Week 4, 8, 13 and 26 |
| 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. | Week 39 and 52 |
| 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. | Baseline, Week 4, 8, 13 and 26 |
| 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. | Baseline, Week 4, 8, 13, 26, 39 and 52 |
| 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. | Baseline and Week 26 |
| 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. | Baseline and Week 52 |
| Baseline, Week 4, 8, 13 and 26 |
| 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. | Baseline, Week 4, 8, 13, 26, 39 and 52 |
| Criciúma |
| Brazil |
| Curitiba | Brazil |
| Goiânia | Brazil |
| Itapira | Brazil |
| Marília | Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
| Sorocaba | Brazil |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| In-Between Main Phase & Extension Phase |
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| Extension Phase |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Positive and Negative Syndrome Scale (PANSS) Total Score | 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. | Mean | Standard Deviation | Units on a scale |
| |||||||||||||||||||||
| Positive and Negative PANSS Subscales Score | 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). | Mean | Standard Deviation | Units on a scale |
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| Personal and Social Performance (PSP) Scale Score | The PSP assesses the degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision. | Mean | Standard Deviation | Units on a scale |
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| Pittsburg Sleep Quality Index (PSQI) | 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. | Mean | Standard Deviation | Units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 52 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 26 |
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| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 52 |
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| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13 and 26 |
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| 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). | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13, 26, 39 and 52 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13 and 26 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13, 26, 39 and 52 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13 and 26 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13, 26, 39 and 52 |
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| 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. | 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. | Posted | Number | Participants | Baseline, Week 4, 8, 13 and 26 |
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| 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. | 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. | Posted | Number | Participants | Week 39 and 52 |
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| 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. | 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. | Posted | Number | Percentage of Participants | Baseline, Week 4, 8, 13 and 26 |
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| 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. | 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. | Posted | Number | Percentage of participants | Baseline, Week 4, 8, 13, 26, 39 and 52 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 26 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 52 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13 and 26 |
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| 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. | 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. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 4, 8, 13, 26, 39 and 52 |
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|
Baseline up to Week 52
The safety analysis population included all the participants that received at least 1 dose of study medication and provided 1 post-baseline information. Here, 215 and 159 participants were inculded in safety analysis set for main phase and extension phase, respectively.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paliperidone ER - Main 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. Dosage was adjusted as per the Investigator's discretion. | 14 | 215 | 144 | 215 | ||
| EG001 | Paliperidone ER - 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. | 3 | 159 | 70 | 159 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychotic disorder NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Schizophrenia NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion NOS | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Somatoform disorder | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Pregnancy NOS | Pregnancy, puerperium and perinatal conditions | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychotic disorder NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Libido decreased | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Schizophrenia NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor retardation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Logorrhea | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Obsessive thoughts | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Impulsive behavior NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hostility | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hallucination NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depressive symptom | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Sleep disorder NOS | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor agitation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Nightmare | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hallucination, auditory | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Psychomotor hyperactivity | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Parkinsonism | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Extrapyramidal disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Aphonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Ageusia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Grand mal convulsion | Nervous system disorders | MedDRA | Non-systematic Assessment |
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| Repetitive speech | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Weight increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Blood prolactin increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting NOS | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Gastritis NOS | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Food poisoning NOS | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Aptyalism | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyslipidemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Diabetes mellitus NOS | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Appetite increased NOS | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertriglyceridemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Hyperglycemia NOS | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pain NOS | General disorders | MedDRA | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Erectile dysfunction NOS | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Ejaculation failure | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Breast discharge | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertension NOS | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Pallor | Vascular disorders | MedDRA | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Infected sebaceous cyst | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Sinusitis NOS | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Breast abscess | Infections and infestations | MedDRA | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Muscle rigidity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Skin lesion NOS | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Acne NOS | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Snoring | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
| |
| Hospitalization | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Cholecystectomy | Surgical and medical procedures | MedDRA | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Eye movement disorder NOS | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Tachycardia NOS | Cardiac disorders | MedDRA | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA | Non-systematic Assessment |
| |
| Hypersensitivity NOS | Immune system disorders | MedDRA | Non-systematic Assessment |
| |
| Lower limb fracture NOS | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Mycosis fungoides NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
| |
| Galactorrhea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
The only disclosure restriction on the PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The Sponsor can require changes to the communication and can extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Group Manager | Jan-Cil Brazil | 55 11 3030-2770 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| 30-39 years |
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| 40-49 years |
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| 50-60 years |
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| 61-69 years |
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| Oriental |
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| Mulatto |
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| Brown |
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