Phase 4
N=40
Safety and Efficacy Study of Paliperidone Extended Release (ER) Among Thai Schizophrenia Participants
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT01387542 ↗Enrolled (actual)
40
Serious AEs
2.5%
Results posted
Mar 2013
Primary outcome: Primary: Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 — 3.55; 0.82 Units on a scale — p=0.000
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Paliperidone extended release (ER) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen-Cilag Ltd.,Thailand
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale at Week 10 |
3.55; 0.82 | 0.000 sig |
| PRIMARY Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 2 |
58.95; -4.289 | 0.009 sig |
| PRIMARY Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 6 |
-7.053 | 0.001 sig |
| PRIMARY Change From Baseline in Personal and Social Performance (PSP) Total Score at Week 10 |
-9.868 | 0.000 sig |
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.
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
Data sourced from ClinicalTrials.gov (NCT01387542). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.