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Medical Charts Reviews of Patients With Long-Term Treatment of Risperidone Long-Acting Injectable
This study has been completed.
First Received: March 24, 2008   No Changes Posted
Sponsored by: Johnson & Johnson Taiwan Ltd
Information provided by: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00644852
  Purpose

The purpose of the study is to evaluate the characteristics, clinical responses, and safety issues of patients received long-term treatment of Risperidone long-acting injectable with the aim to assess patient outcomes by existing risk or disease factors, patient characteristics, or previous medication.


Condition Phase
Schizoaffective Disorder
Schizophrenia
Phase IV

Study Type: Observational
Study Design: Retrospective
Official Title: Medical Charts Reviews of Patients With Long-Term Treatment of Risperidone Long-Acting Injectable

Resource links provided by NLM:


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

Estimated Enrollment: 250
Study Start Date: January 2007
Study Completion Date: September 2007
Detailed Description:

This is a non-interventional, retrospective study on the use of Risperidone long-acting injectable . This study is to evaluate the characteristics, clinical responses, and safety issues of patients received long-term treatment of Risperidone with the aim to assess patient outcomes by existing risk or disease factors, patient characteristics, or previous medication.The time duration of data collection will be from 1 year before Risperidone treatment to discontinuation of Risperidone long-acting injectable treatment. Data will be collected from medical charts and other medical records available.The primary efficacy interest of this study is to compare the Hospitalization Days Per Year for psychotic reasons before and after treatment with Risperidone long-acting injectable (this period is defined as starting one month after continuous Risperidone long-acting injectable treatment until last injection) . Full and partial hospitalization days will be collected and calculated separately. The patient's antipsychotic medication (start date, end date, drug, dose and frequency) and the treatment with other (non-antipsychotic) medication will be recorded. Data of records of adverse events (EPS, body weight, drowsiness, sexual problems, etc), frequency, dosage, and change of dosage of Risperidone long-acting injectable (date, reason, dose and frequency) will also be collected.The secondary efficacy interest of this study is the Relapse Rate and the Hospitalization Rate before and after treatment (as defined above).

It is a chart review type of study. No study drug has been used in the study.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females with 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00644852

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

No publications provided

Study ID Numbers: CR013993
Study First Received: March 24, 2008
Last Updated: March 24, 2008
ClinicalTrials.gov Identifier: NCT00644852     History of Changes
Health Authority: Taiwan: Department of Health

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

Study placed in the following topic categories:
Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin
Schizophrenia
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Schizophrenia
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Psychotic Disorders
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 10, 2009