Completed

Korea Post-Marketing Surveillance of Invega Sustenna

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What is being collected

Drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Mental Disorders

+ Schizophrenia Spectrum and Other Psychotic Disorders

+ Schizophrenia

+3 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 2011
See protocol details

Summary

Principal SponsorJanssen Korea, Ltd., Korea
Last updated: April 27, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: May 23, 2011

Actual date on which the first participant was enrolled.

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.

NCT01819818
Principal SponsorJanssen Korea, Ltd., Korea
Last updated: April 27, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

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

3267 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersSchizophrenia Spectrum and Other Psychotic DisordersSchizophrenia

Criteria

2 inclusion criteria required to participate
Participants diagnosed with schizophrenia
Participants prescribed with paliperidone palmitate for acute or maintenance treatment
1 exclusion criteria prevent from participating
Participants who received paliperidone palmitate for other than the approved indication

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

KyungKi, South KoreaOpen in Google Maps
CompletedOne Study Center