A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients
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|ClinicalTrials.gov Identifier: NCT01819818|
Recruitment Status : Recruiting
First Posted : March 28, 2013
Last Update Posted : October 22, 2018
|Condition or disease||Intervention/treatment|
|Schizophrenia||Drug: No intervention|
|Study Type :||Observational|
|Estimated Enrollment :||3000 participants|
|Official Title:||Korea Post-Marketing Surveillance of Invega Sustenna|
|Actual Study Start Date :||May 23, 2011|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Drug: No intervention
This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.
- Number of participants with adverse events up to Week 9 [ Time Frame: Up to Week 9 ]
- Number of participants with adverse events up to Week 25 [ Time Frame: Up to Week 25 ]
- Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819818
|Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:||JNJ.CT@sylogent.com|
|Korea, Republic of|
|Kyungki, Korea, Republic of, 220-701|
|Study Director:||Janssen Korea, Ltd., Korea Clinical Trial||Janssen Korea, Ltd., Korea|