A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of paliperidone palmitate over a 9-week period for participants with schizophrenia in Korea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
This is an open-label (all people know the identity of the intervention), multi-center, prospective (look forward using observations collected following participant enrollment), non-comparative, non-randomized (the study medication is not assigned by chance), study. Safety and efficacy of paliperidone palmitate will be observed in Korean schizophrenic participants for 25 weeks. Approximately 3000 participants will be observed in this study and the study duration will be 25 weeks. Safety evaluations will include assessment of adverse events, concomitant medications, physical examination, and psychiatric history.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Paliperidone palmitate
|
Drug: No intervention
This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.
|
Outcome Measures
Primary Outcome Measures
- Number of participants with adverse events up to Week 9 [Up to Week 9]
Secondary Outcome Measures
- Number of participants with adverse events up to Week 25 [Up to Week 25]
- Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores [Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25]
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) scale scores [Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25]
This PSP assesses the degree of a participants dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; =< 30, functioning so poorly as to require intensive supervision.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants diagnosed with schizophrenia
-
Participants prescribed with paliperidone palmitate for acute or maintenance treatment
Exclusion Criteria:
- Participants who received paliperidone palmitate for other than the approved indication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | KyungKi | Korea, Republic of |
Sponsors and Collaborators
- Janssen Korea, Ltd., Korea
Investigators
- Study Director: Janssen Korea, Ltd., Korea Clinical Trial, Janssen Korea, Ltd., Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CR100810
- R092670SCH4007
- PALM-KOR-PMS