Status:
COMPLETED
An Efficacy and Safety Study of Long Acting Injectable Risperidone and Oral Risperidone in Participants With Schizophrenia or Schizoaffective Disorder
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Schizophrenia
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of long acting injectable (LAI) risperidone and oral risperidone treatment on participants with schizophrenia (psychiatric disorder wit...
Detailed Description
This is a randomized (treatment group assigned by chance), open-label (all involved people know the identity of the study drug), active-controlled study to evaluate the improvement in social functioni...
Eligibility Criteria
Inclusion
- Participants who will understand the objectives and necessary procedures of the study and have signed the informed consent form which specified that they were willing to participate in the study - Participants with schizophrenia or schizoaffective disorder requiring long-term antipsychotic drug therapy - Participants with pre-morbid global assessment of functioning score of 71 or higher at Screening - Participants who do not present clinically significant abnormality in biochemistry and electrocardiography - Participants who will be compliant with the study requirements (that is, filling in the questionnaire by themselves) and who are capable of actually performing and willing to implementing them
Exclusion
- Participants who had taken clozapine for the past three months - Participants with mental retardation (Intelligence Quotient less than 70 at the screening) - Participants with history of or currently with a serious disease (cardiovascular, respiratory, neurological \[including seizures or significant cerebrovascular\], renal, hepatic, hematologic, endocrine, immunologic or other systemic disease) including clinically relevant abnormal level - Participants who have an allergic or hypersensitive reaction to risperidone or who are unresponsive to risperidone - Pregnant or lactating female participants
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00992407
Start Date
December 1 2007
End Date
December 1 2010
Last Update
March 11 2014
Active Locations (1)
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1
Ansan, South Korea