SchizophreniaNCT01819818
A Study to Observe the Safety and Tolerability of Paliperidone Palmitate (Invega Sustenna) in Korean Schizophrenic Patients
An observational study of Schizophrenia, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Injection or infusion
- How many people
- 3,267 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 May 2011to 29 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with schizophrenia and prescribed with paliperidone palmitate for acute or maintenance treatment.
Who may be able to join
- Participants diagnosed with schizophrenia
- Participants prescribed with paliperidone palmitate for acute or maintenance treatment
Who cannot join
- Participants who received paliperidone palmitate for other than the approved indication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- No intervention
- Keywords
- Schizophrenia, Paliperidone palmitate, Invega, Sustenna, Korea
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionDrug
This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone palmitate | Not described Receives: Drug: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events up to Week 9
Measured: Up to Week 9
Secondary outcomes (3)
Number of participants with adverse events up to Week 25
Measured: Up to Week 25
Change from baseline in Clinical Global impression-Severity (CGI-S) scale scores
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.
Measured: 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
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.
Measured: Baseline (Day 1), Week 5, Week 9, Week 13, Week 17, Week 21, and Week 25
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study start23 May 2011
- Primary completion29 Nov 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819818
- Sponsor's protocol ID
- CR100810
- Other IDs
- R092670SCH4007, PALM-KOR-PMS
- Status last verified
- Apr 2025
- First submitted
- 18 Jan 2013
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korea Post-Marketing Surveillance of Invega Sustenna
- ClinicalTrials.gov ID
- NCT01819818
- Acronym / sponsor ID
- CR100810
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone palmitate, Invega, Sustenna, Korea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,267 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- 23 May 2011 (actual)
- Primary completion
- 29 Nov 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 28 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone palmitate | – | Drug: No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with schizophrenia and prescribed with paliperidone palmitate for acute or maintenance treatment.
Key inclusion criteria (2 listed)
- Participants diagnosed with schizophrenia
- Participants prescribed with paliperidone palmitate for acute or maintenance treatment
Key exclusion criteria (1 listed)
- Participants who received paliperidone palmitate for other than the approved indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed. | Drug | Paliperidone palmitate |
Primary outcome
Number of participants with adverse events up to Week 9
Time frame: Up to Week 9
3 secondary outcomes
Number of participants with adverse events up to Week 25
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen Korea, Ltd., Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with adverse events up to Week 9 (time frame: Up to Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.