Back to resultsSafety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants (PRESENT)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Paliperidone extended release (ER)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Paliperidone Extended Release (ER), INVEGA
Eligibility Criteria
Inclusion Criteria:
- Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
- Participants unsatisfied with their previous treatment
- Previously or currently on oral atypical antipsychotics
Exclusion Criteria:
- Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
- History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
- History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
- Pregnant or breast-feeding female
- Participation in an investigational drug trial within 30 days prior to selection
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone Extended Release (ER)
Arm Description
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
Outcomes
Primary Outcome Measures
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 .
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01387542
First Posted
June 30, 2011
Last Updated
January 29, 2013
Sponsor
Janssen-Cilag Ltd.,Thailand
1. Study Identification
Unique Protocol Identification Number
NCT01387542
Brief Title
Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
Acronym
PRESENT
Official Title
An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.,Thailand
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Paliperidone Extended Release (ER), INVEGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone Extended Release (ER)
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Paliperidone extended release (ER)
Intervention Description
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
Primary Outcome Measure Information:
Title
Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10
Description
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 .
Time Frame
Baseline, Week 10
Title
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2
Description
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.
Time Frame
Baseline, Week 2
Title
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6
Description
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.
Time Frame
Baseline, Week 6
Title
Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10
Description
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.
Time Frame
Baseline, Week 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
Participants unsatisfied with their previous treatment
Previously or currently on oral atypical antipsychotics
Exclusion Criteria:
Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities
History or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body)
History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Pregnant or breast-feeding female
Participation in an investigational drug trial within 30 days prior to selection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd.,Thailand Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.,Thailand
Official's Role
Study Director
Facility Information:
City
Chiang Mai
Country
Thailand
City
Songkhla
Country
Thailand
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=1106&filename=CR015976_CSR.pdf
Description
An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)
Learn more about this trial
Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
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