SchizophreniaNCT00511628
Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
An observational study of Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag, S.A..
Trial summary
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
- What is being tested?
- Risperidone
- How many people
- 1,717 participants
- Where
- No sites listed yet
- Study dates
- Jul 2001to Jan 2003
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25; Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25 ; Patients that have shown intolerance to a previous antipsychotic treatment
Who may be able to join
- Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25
- Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25
- Patients that have shown intolerance to a previous antipsychotic treatment
Who cannot join
- Pregnant or lactating patients
- Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
- Patients with neurology pathology except Parkinsonism induced by neuroleptics
- Patients with other severe concomitant pathology
- Patients treated with Risperidone in the last 30 days.
About this study
Official title: BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index
The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
Read the detailed description
This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) >25, or for patients that have increased their body weight >7% in the last year with the previous treatment (even with a BMI< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I \& II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).
- Being tested
- Risperidone
- Keywords
- Schizophrenia, Risperidone, Schizoaffective disorder, Schizophreniform disorder, Weight gain
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RisperidoneDrug
As prescribed
| Study group | Role | What they receive |
|---|---|---|
| 001 | Risperidone As prescribed Receives: Drug: Risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Evaluation of Risperidone in patients who are overweight and/or obese
Measured: 6 months
Secondary outcomes (1)
Effectiveness
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2007 (estimated)
- Study startJul 2001
- Study completionJan 2003
Why it stopped: Due to the achievement of minimum required sample size and new changes in local regulations.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial, Study director, Janssen-Cilag, S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00511628
- Sponsor's protocol ID
- CR009313
- Status last verified
- Mar 2011
- First submitted
- 2 Aug 2007
- Last updated
- 19 May 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index
- ClinicalTrials.gov ID
- NCT00511628
- Acronym / sponsor ID
- CR009313
- Keywords
- Schizophrenia, Risperidone, Schizoaffective disorder, Schizophreniform disorder, Weight gain
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to the achievement of minimum required sample size and new changes in local regulations.
- Enrolment
- 1,717 participants (actual)
- Lead sponsor
- Janssen-Cilag, S.A.Industry (pharma, biotech, devices)
- Study start
- Jul 2001
- Study completion
- Jan 2003 (actual)
- First posted
- 6 Aug 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 study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.
Detailed description
This is an observational, multicenter, open and prospective study. The primary objective is to evaluate safety of risperidone in patients who are overweight and/or obese. It is expected to enroll 1500 patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI (Body Mass Index) >25, or for patients that have increased their body weight >7% in the last year with the previous treatment (even with a BMI< 25), and for patients that have shown intolerance to a previous antipsychotic treatment. The study drug is risperidone, 3-6 mg per day, orally, during the study period (6 months). All data collected will be prospective and will include the following: demographic data, psychiatric history and comorbidities, concomitant treatment, body weight, treatment history , other illness related to obesity ( such as diabetes mellitus I \& II, hypertension and hypercholesterolemia) and adverse events. Observational Study: Risperidone, 3-6 mg per day, orally, during the study period (6 months).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: RisperidoneRisperidone As prescribed |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25; Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25 ; Patients that have shown intolerance to a previous antipsychotic treatment
Key inclusion criteria (3 listed)
- Patients with Schizophrenia or Schizoaffective disorder, in which physicians considered the use of risperidone as treatment under clinical practice with a BMI >25
- Patients have increased their body weight >7% in the last year with the previous treatment even with a BMI< 25
- Patients that have shown intolerance to a previous antipsychotic treatment
Key exclusion criteria (5 listed)
- Pregnant or lactating patients
- Patients with psychiatry pathology other than Schizophrenia or schizoaffective disorder
- Patients with neurology pathology except Parkinsonism induced by neuroleptics
- Patients with other severe concomitant pathology
- Patients treated with Risperidone in the last 30 days.
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 |
|---|---|---|
| RisperidoneAs prescribed | Drug | 001 |
Primary outcome
Safety Evaluation of Risperidone in patients who are overweight and/or obese
Time frame: 6 months
1 secondary outcome
Effectiveness
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Due to the achievement of minimum required sample size and new changes in local regulations.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2011.
- Study on the safety of risperidone on obese or overweight patients with schizophrenia.Link 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-Cilag S.A. (formerly Janssen Sp) Clinical Trial study director
Janssen-Cilag, S.A.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder, run by Janssen-Cilag, S.A..
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 3 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: stopped early, as of the sponsor's last update on 19 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.
Are results available for this study?
The study was stopped early (reason given: Due to the achievement of minimum required sample size and new changes in local regulations.). Results are not available in the source record.
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?
Safety Evaluation of Risperidone in patients who are overweight and/or obese (time frame: 6 months). 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 19 May 2011; AzTrials last refreshed its copy on 6 Nov 2026.