NCT01819818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,267

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 23, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 28, 2013

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2019

Completed
Last Updated

April 27, 2025

Status Verified

April 1, 2025

Enrollment Period

8.5 years

First QC Date

January 18, 2013

Last Update Submit

April 25, 2025

Conditions

Schizophrenia

Keywords

SchizophreniaPaliperidone palmitateInvegaSustennaKorea

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events up to Week 9

    Up to Week 9

Secondary Outcomes (3)

  • Number of participants with adverse events up to Week 25

    Up to Week 25

  • 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

  • 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

Study Arms (1)

Paliperidone palmitate

Drug: No intervention

Interventions

No interventionDRUG

This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.

Paliperidone palmitate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participants diagnosed with schizophrenia
  • Participants prescribed with paliperidone palmitate for acute or maintenance treatment

You may not qualify if:

  • Participants who received paliperidone palmitate for other than the approved indication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

KyungKi, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Janssen Korea, Ltd., Korea Clinical Trial

    Janssen Korea, Ltd., Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

March 28, 2013

Study Start

May 23, 2011

Primary Completion

November 29, 2019

Study Completion

November 29, 2019

Last Updated

April 27, 2025

Record last verified: 2025-04

Locations

KR(1)