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OpenTrials
Completed

NCT Number: NCT01819818

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Sex eligibility

All sexes

Study type

Observational

Primary location

KyungKi, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Drug

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

Primary outcomes

  1. Number of participants with adverse events up to Week 9

    Time frame: Up to Week 9

Secondary outcomes

  1. Number of participants with adverse events up to Week 25

    Time frame: Up to Week 25

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Janssen Korea, Ltd., Korea

Industry

Registry information

Official study title

Korea Post-Marketing Surveillance of Invega Sustenna

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Mar 28, 2013
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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