SchizophreniaPhase 3NCT00236548
Evaluation of the Usefulness to Doctors of the Risperdal Consta Treatment Guidebook Over a Three-month Period During Which Adult Patients With Schizophrenia or Schizoaffective Disorder Are Switching From Daily Doses or Risperidone Tablets to Long-acting Risperidone by Injection
A Phase 3 study testing risperidone in people with Schizophrenia and Psychotic Disorders, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to assess the usefulness of the Risperdal® Consta® Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Psychotic Disorders
- What is being tested?
- risperidone
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Jan 2003
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- taking oral risperidone at doses of 2 to 6 milligrams per day for 4 weeks before start of study
- if female, using birth control.
Who cannot join
- Hospitalized within past 4 weeks to treat exacerbation of symptoms of schizophrenia
- at risk for injury to self or others
- had electroconvulsive therapy within past year
- presence of liver or kidney impairment
- use of oral antipsychotics (other than risperidone) within past 4 weeks, of injected antipsychotics within past 3 months, of clozapine within past 60 days, or of long-acting risperidone in an earlier study
- pregnant or breast-feeding
- not using birth control
- abusing drugs or alcohol.
About this study
Official title: An Open-label Evaluation of the Utility of the RISPERDAL CONSTA Treatment Guidebook During Transition of Adult Patients With Schizophrenia or Schizoaffective Disorder to RISPERDAL CONSTA (Risperidone) Treatment Over Three Months in the Community Mental Health Center (CMHC) Setting
The purpose of this study is to assess the usefulness of the Risperdal® Consta® Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. The study will also evaluate the effectiveness and safety of long-acting risperidone and its effect on patient satisfaction.
Read the detailed description
Many patients who take oral medication to treat schizophrenia or schizoaffective disorder have trouble taking their medication every day. They may not want to take it, or they may just forget. Risperidone injections, given once every 2 weeks, are expected to be just as effective as risperidone tablets taken once a day. The option of getting an injection every 2 weeks rather than taking a tablet every day may help patients keep to their medication administration schedule and could help to reduce the symptoms of their disease. The study will assess the usefulness of the Risperdal® Consta® Treatment Guidebook in a Community Mental Health Center setting, over a period of three months. This Guidebook was designed to help doctors switch adult patients from oral risperidone tablets to long-acting risperidone given once every 2 weeks by injection. During the study, patients will continue to take oral risperidone for 2 weeks following initiation of risperidone injections, which will be given every 2 weeks during a 12-week period. Physical examinations and laboratory tests will be performed to test the safety of the risperidone injections. Both the patient and the doctor will be asked questions about the usefulness of the guidebook and the effectiveness of the injections. The objective of this study is to demonstrate the effectiveness of the Risperdal® Consta™ Treatment Guidebook in switching patients with schizophrenia and schizoaffective disorder from daily oral risperidone to long-acting risperidone injections. In addition, safety evaluations are assessed throughout the study. Risperidone oral tablets, 2 to 6 milligrams per day for the first 2 weeks after initiation of long-acting risperidone injections; long-acting risperidone injections are given in doses of 25, 37.5, or 50 milligrams per 2 milliliter injection once every 2 weeks for 12 weeks.
- Conditions
- Schizophrenia, Psychotic Disorders
- Being tested
- risperidone
- Keywords
- Schizophrenia, schizoaffective disorder, patient compliance, long-acting risperidone, intramuscular injection, Treatment Guidebook
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Patient Compliance
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.
Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines
Secondary outcomes (1)
Effectiveness of study drug measured by the Clinical Global Impression scale; safety by assessing treatment-emergent adverse events, vital signs, laboratory tests or electrocardiogram changes; quality of life by the Schizophrenia Quality of Life Scale
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study completionJan 2003
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 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
- NCT00236548
- Sponsor's protocol ID
- CR002896
- Status last verified
- Mar 2011
- First submitted
- 7 Oct 2005
- Last updated
- 18 May 2011
- Results posted
- No
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
- An Open-label Evaluation of the Utility of the RISPERDAL CONSTA Treatment Guidebook During Transition of Adult Patients With Schizophrenia or Schizoaffective Disorder to RISPERDAL CONSTA (Risperidone) Treatment Over Three Months in the Community Mental Health Center (CMHC) Setting
- ClinicalTrials.gov ID
- NCT00236548
- Acronym / sponsor ID
- CR002896
- Conditions
- Schizophrenia, Psychotic Disorders
- Keywords
- Schizophrenia, schizoaffective disorder, patient compliance, long-acting risperidone, intramuscular injection, Treatment Guidebook
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study completion
- Jan 2003 (actual)
- First posted
- 12 Oct 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 assess the usefulness of the Risperdal® Consta® Treatment Guidebook in helping the doctor switch the adult patient from taking risperidone tablets daily by mouth to taking long-acting risperidone by injection. The study will also evaluate the effectiveness and safety of long-acting risperidone and its effect on patient satisfaction.
Detailed description
Many patients who take oral medication to treat schizophrenia or schizoaffective disorder have trouble taking their medication every day. They may not want to take it, or they may just forget. Risperidone injections, given once every 2 weeks, are expected to be just as effective as risperidone tablets taken once a day. The option of getting an injection every 2 weeks rather than taking a tablet every day may help patients keep to their medication administration schedule and could help to reduce the symptoms of their disease. The study will assess the usefulness of the Risperdal® Consta® Treatment Guidebook in a Community Mental Health Center setting, over a period of three months. This Guidebook was designed to help doctors switch adult patients from oral risperidone tablets to long-acting risperidone given once every 2 weeks by injection. During the study, patients will continue to take oral risperidone for 2 weeks following initiation of risperidone injections, which will be given every 2 weeks during a 12-week period. Physical examinations and laboratory tests will be performed to test the safety of the risperidone injections. Both the patient and the doctor will be asked questions about the usefulness of the guidebook and the effectiveness of the injections. The objective of this study is to demonstrate the effectiveness of the Risperdal® Consta™ Treatment Guidebook in switching patients with schizophrenia and schizoaffective disorder from daily oral risperidone to long-acting risperidone injections. In addition, safety evaluations are assessed throughout the study. Risperidone oral tablets, 2 to 6 milligrams per day for the first 2 weeks after initiation of long-acting risperidone injections; long-acting risperidone injections are given in doses of 25, 37.5, or 50 milligrams per 2 milliliter injection once every 2 weeks for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder
- stable with respect to disease symptoms and other medical conditions
- taking oral risperidone at doses of 2 to 6 milligrams per day for 4 weeks before start of study
- if female, using birth control.
Key exclusion criteria (8 listed)
- Hospitalized within past 4 weeks to treat exacerbation of symptoms of schizophrenia
- at risk for injury to self or others
- had electroconvulsive therapy within past year
- presence of liver or kidney impairment
- use of oral antipsychotics (other than risperidone) within past 4 weeks, of injected antipsychotics within past 3 months, of clozapine within past 60 days, or of long-acting risperidone in an earlier study
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
Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines
1 secondary outcome
Effectiveness of study drug measured by the Clinical Global Impression scale; safety by assessing treatment-emergent adverse events, vital signs, laboratory tests or electrocardiogram changes; quality of life by the Schizophrenia Quality of Life Scale
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.
- An open-label evaluation of the RISPERDAL� CONSTA� Treatment Guidebook during transition of adult patients with schizophrenia or schizoaffective disorder to RISPERDAL� CONSTA� over 3 months in the Community Mental Health Center (CMHC) settingLink 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 in people with Schizophrenia and Psychotic Disorders, 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 4 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?
Usefulness of the Risperdal® Consta® Treatment Guidebook; patient and clinician adherence to guidelines. 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 18 May 2011.