Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia

Schizophrenia Clinical Trial

Official title:

BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00511628
• Other study ID #: CR009313
• Status: Terminated
• Phase: N/A
• First received: August 2, 2007
• Last updated: May 18, 2011
• Start date: July 2001
• Est. completion date: January 2003

Study information

• Verified date: March 2011
• Source: Janssen-Cilag, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Drug Agency
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate the safety of risperidone treatment in patients who are overweight and/or obese.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1717
• Est. completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Disease
• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia
• Schizophreniform Disorder

Intervention

Drug:
• Risperidone
As prescribed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen-Cilag, S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety Evaluation of Risperidone in patients who are overweight and/or obese		6 months	No
Secondary	Effectiveness		6 months	No

External Links

•   Study on the safety of risperidone on obese or overweight patients with schizophrenia.