SchizophreniaPhase 3NCT00297388
A Study of How Long it Takes a Patient to Relapse After Switching From an Oral Antipsychotic to One of Two Doses of Long-acting Risperidone Injections in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 3 study testing Risperidone, long-acting injectable in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Risperidone, long-acting injectable
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Sep 2004
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
- patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient
- if female, using birth control.
Who cannot join
- Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks
- at risk to self or others
- use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months
- presence of liver or kidney damage
- history of neuroleptic malignant syndrome
- if pregnant or breast-feeding
- not using birth control
- abusing drugs or alcohol.
About this study
Official title: A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
The purpose of this study is to assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.
Read the detailed description
Results from studies of older long-acting injectable antipsychotics (not risperidone) show that patients tend to relapse (which means start having symptoms again) when they are given low doses. However, increasing the dose may cause more side effects. This study will measure the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses of long-acting risperidone injections (shots). The patients will be assigned to a dose of either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week period, they will receive the injectable risperidone only. Patients will be asked questions at each visit to help determine the effectiveness of the drug as assessed by the Clinical Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom Rating Scale and self-reported treatment-emergent adverse events. Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks following the first injection of risperidone.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Risperidone, long-acting injectable
- Keywords
- schizophrenia, schizoaffective disorder, long-acting risperidone, intramuscular injection risperidone, risperidone
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Risperidone, long-acting injectableDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Risperidone effectiveness is measured by time to relapse within the 52 week period.
Secondary outcomes (1)
Effectiveness of the drug is assessed by the Clinical Global Impression Scale and Positive and Negative Syndrome Scale; safety as assessed by the Extrapyramidal Symptom Rating Scale and treatment-emergent adverse events during the 52 week period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2006 (estimated)
- Study completionSep 2004
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297388
- Sponsor's protocol ID
- CR002899
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2006
- Last updated
- 18 May 2011
- Results posted
- No
Publications
Simpson GM, Mahmoud RA, Lasser RA, Kujawa M, Bossie CA, Turkoz I, Rodriguez S, Gharabawi GM. A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2006 Aug;67(8):1194-203. doi: 10.4088/jcp.v67n0804.
PubMed 16965196
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-wk Prospective, Randomized, Double-blind, Multicenter Study of Relapse Following Transition From Oral Antipsychotic Medication to 2 Different Doses (25 or 50 mg Every 2 Wks) of Risperidone Long-acting Microspheres (Risperdal� CONSTA�) in Adults With Schizophrenia or Schizoaffective Disorder
- ClinicalTrials.gov ID
- NCT00297388
- Acronym / sponsor ID
- CR002899
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- schizophrenia, schizoaffective disorder, long-acting risperidone, intramuscular injection risperidone, risperidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study completion
- Sep 2004 (actual)
- First posted
- 28 Feb 2006 (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 assess the time for patients to relapse when switched from an oral antipsychotic to one of two doses of long-acting risperidone injection (shots). Risperidone has been used successfully to treat schizophrenia and schizoaffective disorder.
Detailed description
Results from studies of older long-acting injectable antipsychotics (not risperidone) show that patients tend to relapse (which means start having symptoms again) when they are given low doses. However, increasing the dose may cause more side effects. This study will measure the time to relapse during a 52-week period in patients with schizophrenia or schizoaffective disorder who are switched from an oral antipsychotic (one taken by mouth) to one of two doses of long-acting risperidone injections (shots). The patients will be assigned to a dose of either 25 or 50 milligrams per injection every 2 weeks. Patients continue to take their usual oral antipsychotic medications up to 3 weeks following the first injection. After this 3-week period, they will receive the injectable risperidone only. Patients will be asked questions at each visit to help determine the effectiveness of the drug as assessed by the Clinical Global Impression Scale and the Positive and Negative Syndrome Scale. The safety of the drug will be based on patient signs and symptoms assessed according to the Extrapyramidal Symptom Rating Scale and self-reported treatment-emergent adverse events. Long-acting risperidone injection, 25 or 50 milligrams per injection, every 2 weeks for 52 weeks. Patients will continue to take their current oral antipsychotics for up to 3 weeks following the first injection of risperidone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- stable on any oral antipsychotic drug (except clozapine) for 4 weeks before the study
- patients identify a relative or acquaintance who can complete a questionnaire with additional information about the patient
- if female, using birth control.
Key exclusion criteria (8 listed)
- Patient is not eligible if currently hospitalized, or was treated for an acute disease-related crisis within the past 4 weeks
- at risk to self or others
- use of injectable antipsychotic drugs or electroconvulsive therapy within past 6 months, or currently using carbamazepineor an oral antipsychotic drug in a dose that is higher than 8 milligrams per day in risperidone equivalents, of long-acting risperidone in an earlier study, of clozapine, or use of investigational drugs within 30 days, or of electroconvulsive therapy within past 6 months
- presence of liver or kidney damage
- history of neuroleptic malignant syndrome
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, long-acting injectable | Drug | – |
Primary outcome
Risperidone effectiveness is measured by time to relapse within the 52 week period.
1 secondary outcome
Effectiveness of the drug is assessed by the Clinical Global Impression Scale and Positive and Negative Syndrome Scale; safety as assessed by the Extrapyramidal Symptom Rating Scale and treatment-emergent adverse events during the 52 week period.
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 18 May 2011.
- Results publication: PubMed 16965196Simpson GM, Mahmoud RA, Lasser RA, Kujawa M, Bossie CA, Turkoz I, Rodriguez S, Gharabawi GM. A 1-year double-blind study of 2 doses of long-acting risperidone in stable patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2006 Aug;67(8):1194-203. doi: 10.4088/jcp.v67n0804.
- A 52-week, prospective, randomized, double-blind, multicenter study of relapse following transition from oral antipsychotic medication to two different doses of risperidone long-acting microspheres in adults with schizophrenia or schizoaffective disorderLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Risperidone, long-acting injectable in people with Schizophrenia and Schizoaffective Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 5 inclusion and 8 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 18 May 2011. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Risperidone effectiveness is measured by time to relapse within the 52 week period.. 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 NCT00297388, 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 18 May 2011.