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

May 22, 2014 updated by: Johnson & Johnson Taiwan Ltd
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

342

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This study will enroll patients with diagnosis of Schizophrenia or Schizoaffective disorder by DSM-IV-TR criteria and who have ever been treated with risperidone long-acting injectable for more than 3 months.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Other: Retrospective chart review study
Retrospective study chart review long acting risperidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare the number of days hospitalized for reasons relating to psychosis before and after treatment with risperidone long-acting injectable.
Time Frame: From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.
From one year prior to risperidone treatment until discontinuation of risperidone long acting injectable.

Secondary Outcome Measures

Outcome Measure
Time Frame
Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Taiwan Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 24, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 27, 2008

Study Record Updates

Last Update Posted (Estimate)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR013993

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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