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A Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres (e-STAR)

This study is ongoing, but not recruiting participants.

Sponsored by: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00294008
  Purpose

The purpose of this study is to collect sufficient retrospective outcome data to allow the evaluation of treatment outcomes with long acting medication compared to previous treatments ,document clinical effectiveness and long-term treatment outcomes of long-acting injectable risperidone and prospectively assess medication usage patterns


Condition Intervention Phase
Schizophrenia
Drug: long-acting injectable risperidone
Phase IV

MedlinePlus related topics:   Schizophrenia   

Drug Information available for:   Risperidone   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:   Electronic Schizophrenia Treatment Adherence Registry (e-STAR) : An Observational, International Study to Evaluate Treatment Adherence in Schizophrenia With Long Acting Risperidone Microspheres.

Further study details as provided by Janssen Korea, Ltd., Korea:

Estimated Enrollment:   40
Study Start Date:   December 2004

Detailed Description:

Schizophrenia is a psychiatric disorder affecting 1% of the general population but with treatment costs accounting for approximately 2.5% of total health care expenditures.The majority of health care costs (up to 74%) are accounted for by relapse and subsequent hospitalization or institutionalized care. This protocol proposes a multicentre, retrospective and prospective observational cohort (group of individuals that have similar trait) design, determining aggregate drug usage patterns and commonly used clinical outcomes associated with the use of long-acting injectable risperidone when used as in daily practice. It is believed that such a study can efficiently deliver crucial information for decision makers.

The patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 2 years

  Eligibility
Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients with schizophrenia or schizoaffective disorder - Patients who are an ambulant, or not chronically hospitalized for maximal 6 months at the moment of initiation of study - Patients and/or his/her relative, guardian or legal representative who has signed the informed consent form

Exclusion Criteria:

  • Patient's first antipsychotic treatment ever(treament naïve patients)
  • Participating in any other drug study - Chronically hospitalized and according to physician no prospect of being discharged within the planned observation period - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Previous sensitivity history to risperidone and treatment resistant schizophrenia - Pregnant or breast-feeding female - Female with planned pregnancy within two years
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00294008

Sponsors and Collaborators
Janssen Korea, Ltd., Korea

Investigators
Study Director:     Janssen Korea, Ltd. Clinical Trial     Janssen Korea, Ltd., Korea    
  More Information


Study ID Numbers:   CR005071
First Received:   February 16, 2006
Last Updated:   August 23, 2007
ClinicalTrials.gov Identifier:   NCT00294008
Health Authority:   Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
risperidone  
e-STAR  
Schizoaffective Disorder  
Schizophrenia
long-acting risperidone
Intramuscular injection

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Psychotic Disorders
Serotonin
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
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Serotonin Antagonists
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2008




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