Schizophrenia Clinical Trial
— PRESENTOfficial title:
An Open-label, PRospective Study to Evaluate Social Function and Overall Improvement of Paliperidone ER Treatment in Thai Schizophrenia PatieNT (PRESENT)
Verified date | January 2013 |
Source | Janssen-Cilag Ltd.,Thailand |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Janssen-Cilag Ltd.,Thailand |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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 . | Baseline, Week 10 | No |
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. | Baseline, Week 2 | No |
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. | Baseline, Week 6 | No |
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. | Baseline, Week 10 | No |
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