SchizophreniaPhase 4NCT00216528
A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres
A Phase 4 study testing risperidone in people with Schizophrenia, run by Janssen Korea, Ltd., Korea.
Trial summary
The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- risperidone
- How many people
- 527 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Apr 2007
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form
Who cannot join
- First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)
About this study
Official title: A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)
The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres
Read the detailed description
Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia.
The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year
- Conditions
- Schizophrenia
- Being tested
- risperidone
- Keywords
- Schizophrenia, risperidone, Intramuscular injection, long-acting risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
risperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The symptomatic remission rate at 48 weeks
Secondary outcomes (1)
The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 48 weeks; The change from baseline in SQLS score at 48 weeks; Health-Economic Data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startJul 2005
- Study completionApr 2007
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Korea, Ltd. Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216528
- Sponsor's protocol ID
- CR004966
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 27 Apr 2010
- Results posted
- No
Publications
Lee NY, Kim SH, Cho SJ, Chung YC, Jung IK, Kim CY, Kim DH, Lee DG, Lee YH, Lim WJ, Na YS, Shin SE, Woo JM, Yoon JS, Yoon BH, Ahn YM, Kim YS. A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea. Int Clin Psychopharmacol. 2014 Sep;29(5):279-87. doi: 10.1097/YIC.0000000000000030.
PubMed 24583566
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres (Risperdal Consta)
- ClinicalTrials.gov ID
- NCT00216528
- Acronym / sponsor ID
- CR004966
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, risperidone, Intramuscular injection, long-acting risperidone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jul 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 22 Sep 2005 (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 symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres
Detailed description
Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injectable formulation may eliminate this need for daily medication. This is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia.
The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form
Key exclusion criteria (1 listed)
- First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)
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 |
|---|---|---|
| risperidone | Drug | – |
Primary outcome
The symptomatic remission rate at 48 weeks
1 secondary outcome
The change from baseline in Clinical Global Impression-Severity (CGI-S) score at 48 weeks; The change from baseline in SQLS score at 48 weeks; Health-Economic Data
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 2010.
- Derived from this study: PubMed 24583566Lee NY, Kim SH, Cho SJ, Chung YC, Jung IK, Kim CY, Kim DH, Lee DG, Lee YH, Lim WJ, Na YS, Shin SE, Woo JM, Yoon JS, Yoon BH, Ahn YM, Kim YS. A prospective, open-label study to evaluate symptomatic remission in schizophrenia with risperidone long-acting injectable in Korea. Int Clin Psychopharmacol. 2014 Sep;29(5):279-87. doi: 10.1097/YIC.0000000000000030.
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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. Clinical Trial study director
Janssen Korea, Ltd., Korea
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing risperidone in people with Schizophrenia, run by Janssen Korea, Ltd., 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 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 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The symptomatic remission rate at 48 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 NCT00216528, 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 27 Apr 2010.