A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients

Completed

• Conditions: Schizophrenia
• Interventions: Drug: No intervention

• Registration Number: NCT01819818
• Lead Sponsor: Janssen Korea, Ltd., Korea

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.

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 Timeline

• Study Start: 2011-05-23
• Study First Submitted: 2013-01-18
• Study First Submitted QC: 2013-03-27
• Study First Posted: 2013-03-28
• Primary Completion: 2019-11-29
• Study Completion: 2019-11-29
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3267

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Paliperidone palmitate	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events up to Week 9	Up to Week 9

Secondary Outcome Measures

Name	Time	Method
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.
Number of participants with adverse events up to Week 25	Up to Week 25
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.