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Completed

NCT Number: NCT00644852

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Retrospective chart review study

Other

Retrospective study chart review long acting risperidone

Primary outcomes

  1. 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.

Secondary outcomes

  1. Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Taiwan Ltd

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 27, 2008
Registry last updated
May 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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