SchizophreniaNCT00458367
RiSPECT: Risperdal Safety Protocol Evaluation Consta Treatment, a Post Authorization Safety Survey to Obtain Information on the Safety and Efficacy of Risperidone When Used in Routine Clinical Practice
An observational study of Schizophrenia and Psychotic Disorders, run by Janssen Pharmaceutica N.V., Belgium.
Trial summary
The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Psychotic Disorders, Schizoaffective Disorder
- What is being tested?
- Open label risperidone long acting injectable
- Type of treatment
- Injection or infusion
- How many people
- 5,296 participants
- Where
- No sites listed yet
- Study dates
- Jun 2002to Oct 2006
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local SmPC, are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder.
Who may be able to join
- All patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local Summary of Product Characteristics (SmPC), are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder
Who cannot join
- According to the SmPC, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. These patients must be excluded from the survey
About this study
Official title: Risperdal Safety Protocol Evaluation Consta Treatment; A Post Authorization Safety Survey With RISPERDAL CONSTA TM
The purpose of this research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.
Read the detailed description
This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm, prospective, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visits. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. A secondary objective is to evaluate effectiveness and reasons for initiating risperidone. Each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (RLAI) treatment is determined to be clinically indicated. Risperidone long-acting injectable (RLAI) is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.
- Conditions
- Schizophrenia, Psychotic Disorders, Schizoaffective Disorder
- Being tested
- Open label risperidone long acting injectable
- Keywords
- PASS, Safety Assessment, Efficacy Assessment, long-acting injectable 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.
Open label risperidone long acting injectableDrug
intramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg
| Study group | Role | What they receive |
|---|---|---|
| 001 | Open label risperidone long acting injectable intramuscular injections every 2 weeks for 26 weeks flexible dose 25 to 50 mg Receives: Drug: Open label risperidone long acting injectable |
What is being measured
The primary outcome is the main question the study is designed to answer.
To confirm safety, as identified in phase III clinical trials of risperidone by collecting data (including adverse event information) when the drug is used under marketed conditions in routine clinical practice.
Measured: at baseline and at month 1, 3 and 6.
Secondary outcomes (2)
To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)
Measured: Baseline and at month 1, 3 and 6
To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)
Measured: Baseline and at month 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2007 (estimated)
- Study startJun 2002
- Study completionOct 2006
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 5,296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica N.V., Belgium
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica N.V. Clinical Trial, Study director, Janssen Pharmaceutica N.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458367
- Sponsor's protocol ID
- CR003373
- Status last verified
- Oct 2010
- First submitted
- 6 Apr 2007
- Last updated
- 18 Oct 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risperdal Safety Protocol Evaluation Consta Treatment; A Post Authorization Safety Survey With RISPERDAL CONSTA TM
- ClinicalTrials.gov ID
- NCT00458367
- Acronym / sponsor ID
- CR003373
- Conditions
- Schizophrenia, Psychotic Disorders, Schizoaffective Disorder
- Keywords
- PASS, Safety Assessment, Efficacy Assessment, long-acting injectable risperidone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,296 participants (actual)
- Lead sponsor
- Janssen Pharmaceutica N.V., BelgiumIndustry (pharma, biotech, devices)
- Study start
- Jun 2002
- Study completion
- Oct 2006 (actual)
- First posted
- 10 Apr 2007 (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 research study is to gather information on the safety and efficacy of risperidone when used in routine clinical practice.
Detailed description
This post-authorisation safety survey (PASS) is an international, multicentre, naturalistic, descriptive survey to confirm safety of risperidone in daily practice. This is a single-arm, prospective, observational survey to compare the safety profile between groups defined by existing risk or disease factors or patient characteristics. The study duration is 6 months with 4 patient visits. The primary objective of this PASS is to confirm safety, as identified in phase III clinical trials of risperidone, by collecting data when the drug is used under marketed conditions in routine clinical practice. A secondary objective is to evaluate effectiveness and reasons for initiating risperidone. Each investigator is to document data for 4-10 treated patients for whom risperidone long-acting injectable (RLAI) treatment is determined to be clinically indicated. Risperidone long-acting injectable (RLAI) is given as intramuscular injections every 2 weeks. The starting dose of RLAI will be in accordance with the product label (usually 25 mg). If necessary, the dosage of the injection may be increased gradually. Treatment duration is 26 weeks. To ensure continued antipsychotic coverage until the main release of risperidone from the microspheres, previous antipsychotic therapy will be continued concomitantly during the first three weeks of the study.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Open label risperidone long acting injectableOpen label risperidone long acting injectable intramuscular injections every 2 weeks for 26 weeks flexible dose 25 to 50 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local SmPC, are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder.
Key inclusion criteria (1 listed)
- All patients treated with long-acting injectable risperidone as decided after agreement between the physician and the patient, in accordance with the local Summary of Product Characteristics (SmPC), are eligible for inclusion in this survey. According to the global SmPC, long-acting injectable risperidone is indicated for the treatment of schizophrenia and schizoaffective disorder
Key exclusion criteria (1 listed)
- According to the SmPC, long-acting injectable risperidone is contraindicated in patients with a known hypersensitivity to the product or any of its components. These patients must be excluded from the survey
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 |
|---|---|---|
| Open label risperidone long acting injectableintramuscular injections every 2 weeks for 26 weeks, flexible dose 25 to 50 mg | Drug | 001 |
Primary outcome
To confirm safety, as identified in phase III clinical trials of risperidone by collecting data (including adverse event information) when the drug is used under marketed conditions in routine clinical practice.
Time frame: at baseline and at month 1, 3 and 6.
2 secondary outcomes
To evaluate effectiveness of risperidone long acting injectable (using Clinical Global Impression scale-Severity and Change)
Time frame: Baseline and at month 1, 3 and 6
To evaluate effectiveness of risperidone long acting injectable (using Global Assessment of Functioning scale)
Time frame: Baseline and at month 1, 3 and 6
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 Oct 2010.
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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 Pharmaceutica N.V. Clinical Trial study director
Janssen Pharmaceutica N.V.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Psychotic Disorders, run by Janssen Pharmaceutica N.V., Belgium.
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 18 Oct 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.
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?
To confirm safety, as identified in phase III clinical trials of risperidone by collecting data (including adverse event information) when the drug is used under marketed conditions in routine clinical practice. (time frame: at baseline and at month 1, 3 and 6.). 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 Oct 2010.