Status:
COMPLETED
An Efficacy and Safety Study of Long-Term Risperidone Microspheres in Participants With Schizophrenia
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the long-term efficacy and safety of a long-acting injectable formulation of risperidone (an antipsychotic medication) and its influence on quality of life, in...
Detailed Description
This is an open-label (all people know the identity of the intervention) single-arm, and prospective study (study following participants forward in time) of risperidone microspheres in participants wi...
Eligibility Criteria
Inclusion
- Participants diagnosed with schizophrenia or schizoaffective disorder (in-patients or out-patients)
- Participants currently having their symptoms well controlled with a stable dose of oral antipsychotic medication
- Participants who have signed informed consent form
Exclusion
- Participants who have never received any previous antipsychotic treatment
- Participants who have received clozapine during the last 3 months
- Participants with a serious unstable medical condition, including laboratory abnormalities
- Participants with a 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)
- Female participants who are pregnant or breast-feeding, or are of childbearing age without adequate contraception
Key Trial Info
Start Date :
August 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00269919
Start Date
August 1 2005
End Date
August 1 2008
Last Update
April 16 2014
Active Locations (1)
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1
Seoul, South Korea