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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH3029 | Other Identifier | Janssen-Cilag Colombia | |
| R076477SCH3036 | Other Identifier | Janssen-Cilag Argentina |
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The purpose of this study is to evaluate efficacy, safety and tolerability of flexible, once-daily doses of paliperidone extended-release (ER) in patients with schizophrenia from Argentina and Colombia that previously failed treatment with other antipsychotic agents.
This is a single arm (one group of patients), open-label (all people know the identity of the intervention) multicenter 6-month study. Throughout the study flexible dosing of paliperidone ER in a range of 3 to 12 mg/day may be used. Flexible dosing will allow investigators to adjust the dosage of each patient based on the individual needs. Patients will receive 3, 6, 9 or 12 mg of paliperidone ER once daily for 6 months. The tablets will be taken orally. Adjustment of the dosage will be done at the investigator's discretion, based on the individual patient's clinical response and tolerability to the study drug.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone ER | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score | The PANSS Positive Subscale assesses seven 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). | Baseline, Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag S.A. Clinical Trial | Janssen-Cilag, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buenos Aires | Argentina | |||||
Patients who received paliperidone extended-release (ER) at least once and provide at least 1 post baseline efficacy measurement will be included in the intent-to-treat (ITT) analysis set for efficacy. Patients who received paliperidone ER at least once and provide any post-baseline information will be included in the ITT analysis set for safety.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended-release (ER) | The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended-release (ER) | The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 Total Positive and Negative Syndrome Scale (PANSS) Score | The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia. 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. | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paliperidone Extended-release (ER) | The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychotic episode | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GERENTE MEDICO REGIONAL | Jan-Cil Mexico | 52 55 5237 3410 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
| Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score | 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 26 |
| Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | Baseline, Week 26 |
| Clinical Global Impression-Severity (CGIS) | 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 patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening. | Baseline, Week 26 |
| Personal and Social Performance (PSP) Scale | This PSP assesses the degree of a patient'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. Patients 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. | Baseline, Week 26 |
| Health Status as Measured by Self-rated Health Status Survey SF-36 | The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts. | Baseline, Week 26 |
| Sleep Evaluation Scale | This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well). | Baseline, Week 26 |
| Daytime Drowsiness Evaluation Scale | This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). | Baseline, Week 26 |
| Rosario |
| Argentina |
| Bogotá | Colombia |
| Cali | Colombia |
| Medellín | Colombia |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score | The PANSS Positive Subscale assesses seven 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). | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score | 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). | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Change From Baseline in Total Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score | The PANSS General Psychopathology Subscale Score assesses 16 general psychopathology symptoms. The symptoms are rated on a 7-point scale, with a range of 16 (absent) to 112 (extreme psychopathology). | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Clinical Global Impression-Severity (CGIS) | 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 patient. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill patients". Higher scores indicate worsening. | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Number | participants | Baseline, Week 26 |
|
|
|
| Secondary | Personal and Social Performance (PSP) Scale | This PSP assesses the degree of a patient'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. Patients 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. | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Health Status as Measured by Self-rated Health Status Survey SF-36 | The SF-36 is designed to examine a person's perceived health status. The SF-36 includes one multi-item scale measuring eight health concepts: vitality, physical functioning, bodily pain, general health perceptions, physical role-, emotional role-, social role functioning, and mental health. Answers to each question are scored and summed to produce raw scale scores for each health concept which are then transformed to a 0 - 100 scale, a high score defining a more favorable health state. An aggregate summary measure is calculated by averaging the scores from the eight health concepts. | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Sleep Evaluation Scale | This self-administered scale rates the quality of sleep. Patients will indicate on an 11-point scale how well they have slept in the previous 7 days, from 0 (very badly) to 10 (very well). | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| Secondary | Daytime Drowsiness Evaluation Scale | This self-administered scale rates the daytime drowsiness. Patients will indicate on an 11-point scale how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 10 (all the time). | All participants of the intent-to-treat analysis set for efficacy with evaluable data at each measurement time point. | Posted | Mean | Standard Deviation | scores on a scale | Baseline, Week 26 |
|
|
|
| 7 |
| 95 |
| 39 |
| 95 |
| Clinical deterioration | General disorders |
|
| Appendicitis | Gastrointestinal disorders |
|
| Major depressive disorder | Psychiatric disorders |
|
| Worsening of the psychiatric condition with aggressive behavior | Psychiatric disorders |
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| Insomnia | Psychiatric disorders |
|
| Parkinsonism | Nervous system disorders |
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| D011743 |
| Pyrimidines |
| Mildly ill |
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| Moderately ill |
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| Markedly ill |
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| Severely ill |
|
| Among the most extremely ill |
|