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

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.

Study Overview

• Status: Terminated
• Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder
• Intervention / Treatment: Drug: Risperidone

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 Type: Observational
• Enrollment (Actual): 1717

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
001; Risperidone As prescribed	Drug: Risperidone; As prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety Evaluation of Risperidone in patients who are overweight and/or obese	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Effectiveness	6 months

Collaborators and Investigators

• Sponsor: Janssen-Cilag, S.A.

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: July 1, 2001
• Study Completion (Actual): January 1, 2003

Study Registration Dates

• First Submitted: August 2, 2007
• First Submitted That Met QC Criteria: August 2, 2007
• First Posted (Estimate): August 6, 2007

Study Record Updates

• Last Update Posted (Estimate): May 19, 2011
• Last Update Submitted That Met QC Criteria: May 18, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Schizophrenia; Risperidone; Schizoaffective disorder; Weight gain; Schizophreniform disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Disease; Psychotic Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: CR009313