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

Schizophrenia Clinical Trial

Official title:

Korea Post-Marketing Surveillance of Invega Sustenna

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01819818
• Other study ID #: CR100810
• Secondary ID: R092670SCH4007PA
• Status: Completed
• Start date: May 23, 2011
• Est. completion date: November 29, 2019

Study information

• Verified date: February 2021
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3267
• Est. completion date: November 29, 2019
• Est. primary completion date: November 29, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• No intervention
This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse events up to Week 9		Up to Week 9
Secondary	Number of participants with adverse events up to Week 25		Up to Week 25
Secondary	Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores	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 (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25
Secondary	Change from baseline in Personal and Social Performance (PSP) scale scores	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.	Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25