Status:
COMPLETED
A Study to Evaluate Symptomatic Remission in Schizophrenia With Long Acting Risperidone Microspheres
Lead Sponsor:
Janssen Korea, Ltd., Korea
Conditions:
Schizophrenia
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres
Detailed Description
Although most of Korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. Long-acting injecta...
Eligibility Criteria
Inclusion
- Subjects with schizophrenia or schizoaffective disorder - Subjects who have experienced relapse or re-admission previously - Subject and/or his/her relative, guardian or legal representative who has signed the informed consent form
Exclusion
- First antipsychotic treatment ever - On clozapine during the last 3 months - Serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - Subjects that are previously on concomitant use of Risperdal Consta within 60 days prior to entry - Previous sensitivity history to risperidone - History or current symptoms of tardive dyskinesia - History of neuroleptic malignant syndrome - Pregnant or breast-feeding female - Female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - Norplant TM or Depo-Provera TM. A female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
527 Patients enrolled
Trial Details
Trial ID
NCT00216528
Start Date
July 1 2005
End Date
April 1 2007
Last Update
April 27 2010
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