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

Janssen (J&J Innovative Medicine)

Status: Terminated

Conditions: Schizophreniform Disorder; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Risperidone

Study type: Observational

Funder types: Industry

Identifiers

NCT00511628

CR009313

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,717 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,717 participants in 1 patient group

001

Description:

Risperidone As prescribed

Treatment:

Drug: Risperidone