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

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ClinicalTrials.gov Identifier: NCT01819818
Recruitment Status : Recruiting
First Posted : March 28, 2013
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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.

Condition or disease Intervention/treatment
Schizophrenia Drug: No intervention

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.

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Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Korea Post-Marketing Surveillance of Invega Sustenna
Actual Study Start Date : May 23, 2011
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. Number of participants with adverse events up to Week 9 [ Time Frame: Up to Week 9 ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with schizophrenia and prescribed with paliperidone palmitate for acute or maintenance treatment.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01819818


Contacts
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Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

Locations
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Korea, Republic of
Ilsan hospital Recruiting
Kyungki, Korea, Republic of, 220-701
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
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Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Additional Information:
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Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01819818     History of Changes
Other Study ID Numbers: CR100810
R092670SCH4007 ( Other Identifier: Janssen Korea, Ltd., Korea )
PALM-KOR-PMS ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: March 28, 2013    Key Record Dates
Last Update Posted: October 22, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Korea, Ltd., Korea:
Schizophrenia
Paliperidone palmitate
Invega
Sustenna
Korea

Additional relevant MeSH terms:
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Paliperidone Palmitate
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine D2 Receptor Antagonists
Dopamine Antagonists
Dopamine Agents