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| ID | Type | Description | Link |
|---|---|---|---|
| PAL-KOR-4002 |
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The purpose of this study is to investigate the safety and efficacy of flexibly dosed 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).
This is an open-label, prospective (study following participants forward in time), single arm, and non-comparative study of paliperidone Extended Release(ER) in participants with schizophrenia (after switching from the existing drug to paliperidone ER). The total study duration will be approximately of 48 weeks per participant. The study consists of 2 parts: Screening (that is, 14 days before study commences on Day 1); Treatment (single-oral dose of paliperidone for 48 weeks, dose ranging from 3 to 12 milligram). Efficacy of the participants will primarily be evaluated by Positive and Negative Syndrome Scale. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone | Experimental | Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone | Drug | Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg), 6 mg or 9 mg for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48 | 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 is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48 | 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48 | 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 is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48 | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd., Korea Clinical Trial | Janssen Korea, Ltd., Korea | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone | Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
| Baseline and Week 48 |
| Baseline and Week 48 |
| Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48 | The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Daytime Drowsiness at Week 48 | Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Sleep Quality at Week 48 | Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48 | The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Baseline and Week 48 |
| Chunjoo |
| South Korea |
| Daegu | South Korea |
| Goyang-si | South Korea |
| Ilsan | South Korea |
| Kyounggi | South Korea |
| Kyunggi-Do | South Korea |
| Seoul | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone | Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 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). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| 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). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| 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). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Personal and Social Performance Scale (PSP) Score | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Drug Attitude Inventory (DAI-10) | DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Subjective Well-being Under Neuroleptic (SWN-20) Scale Score | The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Daytime Drowsiness | Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Sleep Quality | Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||||
| Symptom Checklist 90-R (SCL90-R) | The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. | Mean | Standard Deviation | Units on a scale |
|
| 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 48 | 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 is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive Subscale Score at Week 48 | 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Negative Subscale Score at Week 48 | 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 is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - General Psychopathology Subscale Score at Week 48 | 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). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Personal and Social Performance Scale (PSP) Score at Week 48 | The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Drug Attitude Inventory (DAI-10) at Week 48 | The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant). Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale Score at Week 48 | The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Daytime Drowsiness at Week 48 | Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Sleep Quality at Week 48 | Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | millimeter (mm) | Baseline and Week 48 |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 48 | The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline is calculated as value at Baseline minus value at Week 48. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics. | ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. 'N' (number of participants analyzed) signifies the participants evaluable for this measure. | Posted | Mean | Standard Deviation | Units on a scale | Baseline and Week 48 |
|
Baseline up to Week 48
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
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 | Paliperidone oral tablet was administered once daily at a starting dose of either 3 milligram (mg) for 48 weeks, wherein recommended dose was 6 mg and dose range was 3 to 12 mg per day. | 23 | 190 | 109 | 190 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal Hernia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Lumbar Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Subdural Haemorrhage | Injury, poisoning and procedural complications | MedDRA | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Agitated Depression | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Alcoholism | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Completed Suicide | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Confusional State | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Depressive Symptom | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Hallucination, Auditory | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Persecutory Delusion | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Schizophrenia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Suicidal Behaviour | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperprolactinaemia | Endocrine disorders | MedDRA | Non-systematic Assessment |
| |
| Vision Blurred | Eye disorders | MedDRA | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Non-systematic Assessment |
| |
| Gait Disturbance | General disorders | MedDRA | Non-systematic Assessment |
| |
| Weight Decreased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Weight Increased | Investigations | MedDRA | Non-systematic Assessment |
| |
| Muscle Rigidity | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
| |
| Akathisia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Bradykinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dysarthria | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Dystonia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Non-systematic Assessment |
| |
| Amenorrhoea | Reproductive system and breast disorders | MedDRA | Non-systematic Assessment |
|
Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Clinical Research Associate | Clinical Research Team, Medical Affairs Korea | 82-2094-4804 |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068882 | Paliperidone Palmitate |
| ID | Term |
|---|---|
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
Not provided
Not provided
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| Paliperidone ER: Lack of Tolerability |
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| OG001 | Paliperidone ER: Lack of Tolerability | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| OG001 | Paliperidone ER: Lack of Tolerability | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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| OG001 |
| Paliperidone ER: Lack of Tolerability |
Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability in the existing antipsychotic drug). |
| OG002 | Paliperidone ER: Lack of Compliance | Paliperidone ER tablet in dose range of 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug). |
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