Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
A Study of the Efficacy, Safety, and Quality of Life of Patients With Schizophrenia Receiving Treatment With a Long-Acting Injectable Formulation of Risperidone
This study is ongoing, but not recruiting participants.
Sponsored by: Janssen Korea, Ltd., Korea
Information provided by: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT00269919
  Purpose

The purpose of this study is to evaluate the long-term effectiveness and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) in patients with schizophrenia, and its influence on their quality of life.


Condition Intervention Phase
Schizophrenia
Schizoaffective Disorder
Drug: Risperidone long-acting injectable
Phase IV

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: The Efficacy, Safety, and Quality of Life With Long-Term Administration of Long- Acting Risperidone Microspheres (Risperdal® Consta®) in Patients With Schizophrenia

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

Primary Outcome Measures:
  • The change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to 96 weeks

Secondary Outcome Measures:
  • The change in Clinical Global Impression - Severity (CGI-S) score from baseline to 96 weeks; The change in WHO - Quality of Life and GAF (Global Assessment of Functioning) score from baseline to 96 weeks

Estimated Enrollment: 50
Study Start Date: August 2005
Detailed Description:

Although most schizophrenic patients in Korea are currently taking oral antipsychotic medications, it is estimated that up to 75% of them have difficulty in adhering to their daily oral regimen. A long-acting, injectable formulation may eliminate the inconvenience of daily medication. This is a prospective, open-label, single center study to determine the long-term effectiveness and safety of biweekly injections of risperidone microspheres (intramuscular injections of either 25, 37.5, or 50 mg of risperidone, every 2 weeks for 2 years) in schizophrenia patients in Korea, and its influence on their quality of life. The primary measure of effectiveness is the change in total Positive and Negative Syndrome Scale (PANSS) score from baseline to 96 weeks. The study hypothesis is that risperidone microspheres will be effective in the treatment of schizophrenia as measured by the change from baseline in the total Positive and Negative Syndrome Scale (PANSS) score, and with improvements in the quality of life of the patients as measured by the WHO - Quality of Life score and the Global Assessment of Functioning score.

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with schizophrenia or schizoaffective disorder
  • Currently have their symptoms well controlled with a stable dose of oral antipsychotic medication

Exclusion Criteria:

  • Patients who have never received any previous antipsychotic treatment
  • Have received clozapine during the last 3 months
  • Have a serious unstable medical condition, including laboratory abnormalities
  • History of, or current symptoms of tardive dyskinesia (a complication of neuroleptic therapy involving involuntary movements of facial muscles) or neuroleptic malignant syndrome (a rare psychotropic-drug reaction, which may be characterized by confusion, reduced consciousness, high fever or pronounced muscle stiffness)
  • Females who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269919

Locations
Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Study Director: Janssen Korea, Ltd. Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Study ID Numbers: CR002089
Study First Received: December 22, 2005
Last Updated: April 1, 2007
ClinicalTrials.gov Identifier: NCT00269919  
Health Authority: Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Risperidone
long-acting injectable
Schizophrenia

Study placed in the following topic categories:
Schizophrenia
Dopamine
Mental Disorders
Risperidone
Quality of Life
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 January 15, 2009