Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone

Johnson & Johnson (J&J)

Status: Completed

Conditions: Schizophrenia; Schizoaffective Disorder

Treatments: Other: Retrospective chart review study

Study type: Observational

Funder types: Industry

Identifiers

NCT00644852

CR013993

Details and patient eligibility

About

The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone long-acting injectable. The goal is to evaluate patient outcomes based on pre-existing risk or disease factors and past medication use.

Full description

This is an Observational, retrospective study on the use of Risperidone long-acting injectable. The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients receiving long-term treatment of Risperidone. Patient outcomes will be evaluated based on pre-existing risk or disease factors and past medication use. Data will be collected from medical charts and other available medical records from one year prior to risperidone treatment until discontinuation of risperidone long acting injectable. The study will compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable. Information about past use of anti-psychotic medications will be collected. The occurrence and frequency of adverse events [Extra-Pyramidal Symptoms (EPS) - the abnormal body movements sometimes associated with antipsychotic medications, body weight changes, drowsiness, sexual problems] and the dose or change in dose of Risperidone long-acting injectable will also be collected. The study will also investigate the relapse rate and the hospitalization rate before and after treatment. It is a chart review type of study. No study drug has been used in the study.

Enrollment: 342 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria
• Patients who used to be treated with Risperidone long-acting injectable regularly for at least 3 months
• Patients whose medical charts or other medical records are available

Exclusion criteria

• None

Trial design

342 participants in 1 patient group

001

Treatment:

Other: Retrospective chart review study