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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4035 | Other Identifier | Johnson & Johnson Taiwan Ltd | |
| PAL-TWN-MA3 | Other Identifier | Johnson & Johnson Taiwan Ltd |
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The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed paliperidone ER.
This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone ER | Drug | Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS) | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. | End of study (Up to Week 12) |
| Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale | 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). Percentage of participants achieving improvement in PSP score by at least one category was reported. | End of study (Up to Week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| Social Functioning Scale (SFS) Score | The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Taiwan Ltd Clinical Trial | Johnson & Johnson Taiwan Ltd | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone ER | Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone ER | Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion. |
| 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 | Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS) | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. | Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of study (Up to Week 12) |
12 weeks
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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 ER | Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator's discretion. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular Tachycardia | Cardiac disorders | MedDRA Version 12.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA Version 12.1 | 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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Janssen Research & Development | 886 2 23762155 |
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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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| End of study (Up to Week 12) |
| Baseline, Week 12 |
| Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 | 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). | Baseline, Week 12 |
| Withdrawal by Subject |
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| Insufficient Response |
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| Ineligible to Continue |
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| Non-Compliant |
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| Other |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Paliperidone Extended Release (ER) | Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator's discretion. |
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| Secondary | Social Functioning Scale (SFS) Score | The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state. | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here 'N' (Number of Participants Analyzed) signifies those participants who were evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | End of study (Up to Week 12) |
|
|
|
| Primary | Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale | 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). Percentage of participants achieving improvement in PSP score by at least one category was reported. | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. | Posted | Number | 95% Confidence Interval | percentage of participants | End of study (Up to Week 12) |
|
|
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| Other Pre-specified | Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 12 | The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
|
|
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| Other Pre-specified | Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 12 | 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). | ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment. Here, 'n' signifies those participants who were evaluable for this outcome measure at specified time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12 |
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|
| 37 |
| 480 |
| 169 |
| 480 |
| Pulmonary Tuberculosis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
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| Femur Fracture | Injury, poisoning and procedural complications | MedDRA Version 12.1 | Non-systematic Assessment |
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| Aggression | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Alcohol Abuse | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Completed Suicide | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Drug Abuse | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Hallucination, Auditory | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Impulsive Behaviour | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Major Depression | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Schizophrenia | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Suicide Attempt | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Scrotal Ulcer | Reproductive system and breast disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 12.1 | Non-systematic Assessment |
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| Weight Increased | Investigations | MedDRA Version 12.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Extrapyramidal Disorder | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA Version 12.1 | Non-systematic Assessment |
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| D011743 |
| Pyrimidines |