SchizophreniaPhase 4NCT00827840
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
A Phase 4 study testing Paliperidone ER and Risperidone in people with Schizophrenia, run by Chonnam National University Hospital at 1 site in South Korea.
Trial summary
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia. Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER and Risperidone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2008to Feb 2011
- 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
- Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients
- Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
- Patients with ability to complete various questionnaires.
- Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
Who cannot join
- Active psychotic symptoms, including severe behavioral disturbance
- Relevant history of or current presence of any significant or unstable medical disease
- A woman who is pregnant, breast-feeding or planning to become pregnant during the study period
- Patients with the history of serious allergy or multiple adverse drug reactions
- Patients with the history of taking paliperidone ER within 60 days
- Patients with history of taking clozapine within 60 days
- Patients who require the treatment of other medications influencing CNS, except permitted concomitant drugs in advance
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dept. of Psychiatry, Chonnam National Univeristy Hospital
Gwangju, 501-757
About this study
Official title: Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.
Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone
Read the detailed description
This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
Also called Invega
3mg to 12mg of Paliperidone ER once a day
RisperidoneDrug
Also called Risperdal
1 to 6 mg of risperidone once or twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1. Paliperidone ER | Experimental | New antipsychotics Receives: Drug: Paliperidone ER |
| 2 Risperidone | Active comparator | Not described Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive function
Measured: 12 weeks
Secondary outcomes (1)
Positive and Negative Syndrome Scale (PANSS)
Measured: monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2009 (estimated)
- Study startNov 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chonnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea, Ministry of Health, Republic of Korea
- Responsible party
- Principal investigator, Jin-Sang Yoon, Chonnam National University Hospital
- Investigators
- Jin-Sang Yoon, Professor, Principal investigator, Dept. of Psychiatry, Chonnam National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00827840
- Sponsor's protocol ID
- PAL-KOR-9006
- Status last verified
- Dec 2011
- First submitted
- 22 Jan 2009
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim SW, Chung YC, Lee YH, Lee JH, Kim SY, Bae KY, Kim JM, Shin IS, Yoon JS. Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial. Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad.
PubMed 22809972
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paliperidone ER Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia: a Randomized, Open-label, Controlled Trial
- ClinicalTrials.gov ID
- NCT00827840
- Acronym / sponsor ID
- PAL-KOR-9006
- Conditions
- Schizophrenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Chonnam National University HospitalUniversity, hospital or other
- Collaborators
- Janssen Korea, Ltd., Korea, Ministry of Health, Republic of Korea
- Study start
- Nov 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 23 Jan 2009 (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.
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia.
Secondary objectives: To compare the general clinical outcomes (efficacy and safety) after switching to paliperidone ER from risperidone
Detailed description
This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, or to the paliperidone-switch group in which they are switched from risperidone to paliperidone. In the paliperidone-switch group, risperidone will be tapered off during the first 4 weeks of the study, while paliperidone is titrated simultaneously. The doses of both drugs will be adjusted according to the clinical judgment of each research psychiatrist, within 6 mg/day of risperidone and 12 mg/day of paliperidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. Paliperidone ER | Experimental | Drug: Paliperidone ERNew antipsychotics |
| 2 Risperidone | Active comparator | Drug: Risperidone |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients
- Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
- Patients with ability to complete various questionnaires.
- Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
Key exclusion criteria (7 listed)
- Active psychotic symptoms, including severe behavioral disturbance
- Relevant history of or current presence of any significant or unstable medical disease
- A woman who is pregnant, breast-feeding or planning to become pregnant during the study period
- Patients with the history of serious allergy or multiple adverse drug reactions
- Patients with the history of taking paliperidone ER within 60 days
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 ERAlso: Invega3mg to 12mg of Paliperidone ER once a day | Drug | 1. Paliperidone ER |
| RisperidoneAlso: Risperdal1 to 6 mg of risperidone once or twice a day | Drug | 2 Risperidone |
Primary outcome
Neurocognitive function
Time frame: 12 weeks
1 secondary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: monthly
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 23 Dec 2011.
- Derived from this study: PubMed 22809972Kim SW, Chung YC, Lee YH, Lee JH, Kim SY, Bae KY, Kim JM, Shin IS, Yoon JS. Paliperidone ER versus risperidone for neurocognitive function in patients with schizophrenia: a randomized, open-label, controlled trial. Int Clin Psychopharmacol. 2012 Sep;27(5):267-74. doi: 10.1097/YIC.0b013e328356acad.
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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.
Jin-Sang Yoon, Professor principal investigator
Dept. of Psychiatry, Chonnam National University Hospital
1 site 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 and Risperidone in people with Schizophrenia, run by Chonnam National University Hospital 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 4 inclusion and 7 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 23 Dec 2011. 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.
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?
Neurocognitive function (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00827840, which also lists 1 linked publication.
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 23 Dec 2011.