Clinical trial NCT00511628: Study on the Safety of Risperidone on Obese or Overweight Patients With Schizophrenia
Official title: BMI-2002 Study: Evaluation of Functionality and Evolution of Body Weight of Psychotic Patients With a High Body Mass Index
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Schizophrenia
Schizoaffective Disorder
Schizophreniform Disorder
Keywords: Schizophrenia
Risperidone
Schizoaffective disorder
Schizophreniform disorder
Weight gain
Lead sponsor: Janssen-Cilag, S.A.
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 1717
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety Evaluation of Risperidone in patients who are overweight and/or obese
timeFrame: 6 months
Secondary outcomes:
measure: Effectiveness
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Janssen-Cilag, S.A.
name: Janssen-Cilag S.A. (formerly Janssen Sp) Clinical Trial
role: STUDY_DIRECTOR
References: