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| ID | Type | Description | Link |
|---|---|---|---|
| R076477SCH4037 | Other Identifier | Janssen-Cilag Ltd.,Thailand |
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The purpose of this study is to evaluate the effectiveness and safety of paliperidone extended release (ER) treatment in Thai schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) participants.
This is an open-label (all people know the identity of the intervention), non-randomized (the study drug is not assigned by chance) study to evaluate the efficacy and safety of paliperidone ER in adult Thai schizophrenia participants. The study consists of a screening phase and an open-label treatment phase. Study duration will be 10 weeks and participants can either be inpatient or outpatient. The recommended paliperidone ER starting and maintenance dose will be 6 milligram (mg) per day for most participants. Throughout the study, flexible dosing ranging from 3 to 12 mg per day may be used at the discretion of the investigator. Throughout the study, participants will be evaluated for efficacy using clinician rating (Clinical and Global Impressions-Severity [CGI-S] scale, and Personal and Social Performance Scale [PSP]) scales. Safety of the participants will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paliperidone Extended Release (ER) | Experimental | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paliperidone extended release (ER) | Drug | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 | 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. 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 participants". Higher scores indicate worsening . | Baseline, Week 10 |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | Baseline, Week 2 |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | Baseline, Week 6 |
| Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd.,Thailand Clinical Trial | Janssen-Cilag Ltd.,Thailand | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiang Mai | Thailand | |||||
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| Label | URL |
|---|---|
| An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paliperidone Extended Release (ER) | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks |
| 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 |
| 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 Clinical Global Impression Severity (CGI-S) Scale at Week 10 | 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. 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 participants". Higher scores indicate worsening . | Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 10 |
|
10 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 Extended Release (ER) | Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania | Psychiatric disorders | MedDRA version 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Drowsiness | Nervous system disorders | MedDRA version 14.0 | Non-systematic Assessment |
Study had an open-label trial design with lack of a comparator arm; therefore it was difficult to conclude the efficacy and safety results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Affairs Director | Janssen-Cilag Ltd.: 106 Moo 4 Lad Krabang Industrial Estate, Chalongkrung Rd., Lamplatew, Lad Krabang, Bangkok 10520 | +66 2 7397200 | 5888 |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| Baseline, Week 10 |
| Songkhla |
| Thailand |
| Insufficient response |
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| Non-compliant |
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| Lost to Follow-up |
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| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 2 |
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| Primary | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 6 |
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| Primary | Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10 | The PSP scale assesses 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. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. | Intent-To-Treat (ITT) population included participants who received at least 1 dose of study medication and had at least one post-baseline efficacy evaluation. | Posted | Mean | Standard Deviation | Units on a scale | Baseline, Week 10 |
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| 1 |
| 40 |
| 22 |
| 40 |
| Elevated mood | Psychiatric disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Extrapyramidal disorder | Nervous system disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Pruritis | Skin and subcutaneous tissue disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Palpitation | Cardiac disorders | MedDRA version 14.0 | Non-systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA version 14.0 | Non-systematic Assessment |
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The disclosure restriction on the PI is that the sponsor can review results communications prior to publication 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 paper that incorporates confidential information requires Sponsor's written consent. PI will withhold publication for up to an additional 60 days to allow for filing of a patent application.