Sponsor study identifier
Secondary identifiers
OTHER · Janssen-Cilag Ltd.,Thailand
interventional
40
1 country
2
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2010
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
September 2010
Actual (reported)September 2010
Actual (reported)June 30, 2011
Actual (reported)July 4, 2011
Actual (reported)March 5, 2013
Actual (reported)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
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
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
Chiang Mai, Thailand
Songkhla, Thailand
Study had an open-label trial design with lack of a comparator arm; therefore it was difficult to conclude the efficacy and safety results.
Janssen-Cilag Ltd.,Thailand Clinical Trial
Janssen-Cilag Ltd.,Thailand
40 participants (actual enrollment reported by the registry).
First Submitted
June 30, 2011
First Posted
July 4, 2011
Study Start
August 2009
Date type not reportedThis date has not been verified as actual or estimated.
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.
Baseline, Week 10
Contact the study team to confirm eligibility.
Primary Completion
September 2010
Actual (reported)Study Completion
September 2010
Actual (reported)Last Updated
March 5, 2013
Results First Posted
March 5, 2013
Record last verified: 2013-01
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Source: ClinicalTrials.gov.
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