SchizophreniaPhase 4NCT00261430
A 2-year Study of Patients With Schizophrenia Who Are Treated With Long-acting Injectable Risperidone.
A Phase 4 study testing GAIN Acceptance Approach in people with Schizophrenia, run by Janssen, LP.
Trial summary
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- GAIN Acceptance Approach
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Oct 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of schizophrenia
- long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study
- stable with respect to disease symptoms and other medical conditions
- if female, using birth control.
Who cannot join
- At risk to self or others
- use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days
- considered to be resistant to treatment
- pregnant or breast-feeding
- not using birth control.
About this study
Official title: Schizophrenia Treatment Acceptance Response Trial: a 20-week, Open-label, Multicenter, Randomized Study Comparing the Effect of the "GAIN Acceptance Approach Verses the "Approach-as-usual" in Supporting Patient Acceptance of Long-acting Risperidone (Risperdal� CONSTA�) in Adults With Schizophrenia
The purpose of this study is to examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
Read the detailed description
Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.
- Conditions
- Schizophrenia
- Being tested
- GAIN Acceptance Approach
- Keywords
- Schizophrenia, acceptance, motivational enhancement therapy, long-acting risperidone, intramuscular injection, Treatment Guidebook, GAIN Acceptance Approach
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAIN Acceptance ApproachBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the "Gain Acceptance Approach" compared with those switched using the "approach as usual"
Secondary outcomes (1)
Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) to measure disease severity; Patient Attitude/Satisfaction scale and Clinician Attitude/Satisfaction scale after 12 weeks of treatment, measuring satisfaction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2005 (estimated)
- Study completionOct 2004
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen, LP
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen, LP Clinical Trial, Study director, Janssen, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00261430
- Sponsor's protocol ID
- CR002893
- Status last verified
- Apr 2010
- First submitted
- 2 Dec 2005
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schizophrenia Treatment Acceptance Response Trial: a 20-week, Open-label, Multicenter, Randomized Study Comparing the Effect of the "GAIN Acceptance Approach Verses the "Approach-as-usual" in Supporting Patient Acceptance of Long-acting Risperidone (Risperdal� CONSTA�) in Adults With Schizophrenia
- ClinicalTrials.gov ID
- NCT00261430
- Acronym / sponsor ID
- CR002893
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, acceptance, motivational enhancement therapy, long-acting risperidone, intramuscular injection, Treatment Guidebook, GAIN Acceptance Approach
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Janssen, LPIndustry (pharma, biotech, devices)
- Study completion
- Oct 2004 (actual)
- First posted
- 5 Dec 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 examine treatment practices of adult schizophrenia patients by their own doctors, and to assess patient outcomes when treated with long-acting risperidone injection over a two-year period of observation.
Detailed description
Controlled clinical trials for treating schizophrenia often involve selected patients with common characteristics. It is recognized that schizophrenia are much more diverse than those in the clinical setting, and that physician's prescribing practices may vary. The objective of the study is to examine treatment practices for adult schizophrenic patients by their own physicians, and to assess patient outcomes when treated with long-acting risperidone injection. This is a 2-year, prospective, multi-center, longitudinal, observational study in adults with schizophrenia. Physicians will determine the appropriate treatment for their patients, according to their usual practice. Patients starting treatment with long-acting risperidone injections and meeting all the study criteria may enroll in the study. Patients will continue their treatment according to usual care by their physicians. Patients will be asked questions at baseline and every three months for a period of two years to assess: efficacy of the medication, how well the patient is functioning, use of healthcare resources (e.g., emergency room visits, hospitalizations) patient work status, quality of life and patient satisfaction with the medicine. Safety will be monitored throughout the study. A dose of 25, 37.5 or 50 mg of risperidone, administered every 2 weeks by intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia
- long-term use of antipsychotic medication and taking any oral antipsychotic for 4 weeks before the study
- stable with respect to disease symptoms and other medical conditions
- if female, using birth control.
Key exclusion criteria (5 listed)
- At risk to self or others
- use of injectable antipsychotics within the past 6 months, of clozapine, or of investigational drugs within 30 days
- considered to be resistant to treatment
- pregnant or breast-feeding
- not using birth control.
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 |
|---|---|---|
| GAIN Acceptance Approach | Behavioural | – |
Primary outcome
After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the "Gain Acceptance Approach" compared with those switched using the "approach as usual"
1 secondary outcome
Clinical Global Impression of Severity (CGI-S) and Clinical Global Impression of Change (CGI-C) to measure disease severity; Patient Attitude/Satisfaction scale and Clinician Attitude/Satisfaction scale after 12 weeks of treatment, measuring satisfaction
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 17 May 2011.
- Schizophrenia Treatment Acceptance Response TrialLink 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.
Janssen, LP Clinical Trial study director
Janssen, LP
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing GAIN Acceptance Approach in people with Schizophrenia, run by Janssen, LP.
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 5 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 17 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 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?
After 12 weeks of treatment, the percentage of patients accepting long-acting risperidone injection switched using the "Gain Acceptance Approach" compared with those switched using the "approach as usual". 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 17 May 2011.