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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00644852
Enrollment
342
Registered
2008-03-27
Start date
2007-01-31
Completion date
2007-09-30
Last updated
2014-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizoaffective Disorder, Schizophrenia

Keywords

Schizophrenia, Schizoaffective disorder, Risperidone long-acting injectable, Long-term evaluation

Brief 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.

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.

Interventions

OTHERRetrospective chart review study

Retrospective study chart review long acting risperidone

Sponsors

Johnson & Johnson Taiwan Ltd
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026