First Episode PsychosisPhase 4NCT01157585
Efficacy and Safety of Paliperidone ER in First Episode Psychosis
A Phase 4 study testing paliperidone ER in people with First Episode Psychosis, run by Chonbuk National University Hospital at 12 sites in South Korea.
Trial summary
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- First Episode Psychosis
- What is being tested?
- paliperidone ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 12 sitesSouth Korea
- Study dates
- Feb 2010to Feb 2013
- Phase
- Phase 4
- 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 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Who cannot join
- Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
- Needing another nonantipsychotic psychotropic medication at enrollment
- Having a serious or unstable medical illness.
- Pregnant or lactating women or women without adequate contraception will be also excluded.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Department of Psychiatry, Korea University College of Medicine, Ansan Hospital
Ansan
Department of Psychiatry, Kangwon National University College of Medicine
Chunchon
Department of Psychiatry, Kyungpook national University School of Medicine
Daegu
Department of Psychiatry, Eulji University, School of Medicine
Daejeon
Department of Psychiatry, Chonnam National University Medical School
Hwasun
Department of Psychiatry, College of Medicine, Won-Kwang University
Iksan
Department of Psychiatry, Gachon University of Medicine and Science
Incheon
Department of Psychiatry, Chonbuk national University Hospital
Jeonju, 561-712
Department of Psychiatry, Myongji Hospital Kwandong Uni. college of Medicine
Koyang
St. John of God Neuropsychiatric Hospital
Kwangju
department of Neuropsychiatry. Dong-Eui University Medical Center
Pusan
Department of Neuropsychiatry, Soonchunhyang University Hospital
Seoul
About this study
Official title: Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.
- Conditions
- First Episode Psychosis
- Being tested
- paliperidone ER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone ERDrug
8 week prospective study
| Study group | Role | What they receive |
|---|---|---|
| drug | Other | Not described Receives: Drug: paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Measured: week 1
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Measured: week 2
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Measured: week 3
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI
Measured: week 4
Symptoms assessment by objective rating scales
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)
Measured: week 8
Secondary outcomes (4)
Assessment of adverse events by objective rating scales and self report scales profile
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Measured: week 1
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS
Measured: week 2
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS
Measured: week 4
Assessment of adverse events by objective rating scales and self report scales
NIDSS(Neuroleptic induced deficit syndrome scale), BAS, SAS, AIMS, Lipid profile
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for First Episode PsychosisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonbuk National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Responsible party
- Principal investigator, Young Chul Chung, Chonbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01157585
- Sponsor's protocol ID
- CBIRB0912-141
- Status last verified
- Jul 2015
- First submitted
- 30 Jun 2010
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Paliperidone ER in Patients With First Episode Psychosis: an Open-label, Prospective Multi-center Study
- ClinicalTrials.gov ID
- NCT01157585
- Acronym / sponsor ID
- CBIRB0912-141
- Conditions
- First Episode Psychosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Chonbuk National University HospitalUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea
- Study start
- Feb 2010
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Jul 2010 (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 aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| drug | Other | Drug: paliperidone ER |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.
Key exclusion criteria (4 listed)
- Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
- Needing another nonantipsychotic psychotropic medication at enrollment
- Having a serious or unstable medical illness.
- Pregnant or lactating women or women without adequate contraception will be also excluded.
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 |
|---|---|---|
| paliperidone ER8 week prospective study | Drug | drug |
Primary outcome
Symptoms assessment by objective rating scales
Time frame: week 1
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
Time frame: week 2
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
Time frame: week 3
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
Time frame: week 4
PANSS total score, SANS, CGI
Symptoms assessment by objective rating scales
Time frame: week 8
PANSS total score, SANS, CGI, CAI(Cognitive Assessment Interview)
4 secondary outcomes
Assessment of adverse events by objective rating scales and self report scales profile
Time frame: week 1
Assessment of adverse events by objective rating scales and self report scales
Time frame: week 2
Assessment of adverse events by objective rating scales and self report scales
Time frame: week 4
Assessment of adverse events by objective rating scales and self report scales
Time frame: week 8
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 31 Jul 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paliperidone ER in people with First Episode Psychosis, run by Chonbuk National University Hospital at 12 sites 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 1 inclusion and 4 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 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Symptoms assessment by objective rating scales (time frame: week 1). The study lists 5 primary outcomes in all. 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 31 Jul 2015.