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

NCT00644852 | Completed

• 1 other identifier: CR013993
• Study Type: observational
• Target: 342
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 year

Study Arms (1)

001

Other: Retrospective chart review study

Interventions

Retrospective chart review study OTHER

Retrospective study chart review long acting risperidone

001

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2008
• First Posted: March 27, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: May 23, 2014

Record last verified: 2014-05