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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00644852
• Other study ID #: CR013993
• Status: Completed
• Phase: Phase 4
• First received: March 24, 2008
• Last updated: May 22, 2014
• Start date: January 2007
• Est. completion date: September 2007

Study information

• Verified date: May 2014
• Source: Johnson & Johnson Taiwan Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 342
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Other:
• Retrospective chart review study
Retrospective study chart review long acting risperidone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Taiwan Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable.		From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.	No
Secondary	Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable		1 year	No