We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00644852
First Posted: March 27, 2008
Last Update Posted: May 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
  Purpose
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.

Condition Intervention Phase
Schizophrenia Schizoaffective Disorder Other: Retrospective chart review study Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Compare the Relapse Rate and the Hospitalization Rate before patients were treated with risperidone long-acting injectable [ Time Frame: 1 year ]

Enrollment: 342
Study Start Date: January 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Retrospective chart review study
Retrospective study chart review long acting risperidone

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00644852


Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00644852     History of Changes
Other Study ID Numbers: CR013993
First Submitted: March 24, 2008
First Posted: March 27, 2008
Last Update Posted: May 23, 2014
Last Verified: May 2014

Keywords provided by Johnson & Johnson Taiwan Ltd:
Schizophrenia
Schizoaffective disorder
Risperidone long-acting injectable, Long-term evaluation

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents