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

February 1, 2021 updated by: Janssen Korea, Ltd., Korea

Korea Post-Marketing Surveillance of Invega Sustenna

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

3267

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with schizophrenia and prescribed with paliperidone palmitate for acute or maintenance treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events up to Week 9
Time Frame: Up to Week 9
Up to Week 9

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events up to Week 25
Time Frame: Up to Week 25
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.
Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25
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.
Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Korea, Ltd., Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2011

Primary Completion (Actual)

November 29, 2019

Study Completion (Actual)

November 29, 2019

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

March 27, 2013

First Posted (Estimate)

March 28, 2013

Study Record Updates

Last Update Posted (Actual)

February 3, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR100810
  • R092670SCH4007 (Other Identifier: Janssen Korea, Ltd., Korea)
  • PALM-KOR-PMS (Other Identifier: Janssen Korea, Ltd., Korea)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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