Status:
COMPLETED
Paliperidone Extended-Release (ER) Versus Risperidone for Neurocognitive Function in Patients With Schizophrenia
Lead Sponsor:
Chonnam National University Hospital
Collaborating Sponsors:
Janssen Korea, Ltd., Korea
Ministry of Health, Republic of Korea
Conditions:
Schizophrenia
Eligibility:
All Genders
18-59 years
Phase:
PHASE4
Brief Summary
Primary objective: To examine whether the switch to paliperidone ER from risperidone improves cognitive function in stabilized patients with schizophrenia. Secondary objectives: To compare the genera...
Detailed Description
This is a 12-week, randomized, parallel-group, open labeled, flexible-dose study. The patients will be randomized to the risperidone-continuation group in which they continue to receive risperidone, o...
Eligibility Criteria
Inclusion
- Patients diagnosed as schizophrenia by DSM-IV-TR criteria both in inpatients
- Patients who are symptomatically stable, as judged by the treating psychiatrist, and receive a stable dose of risperidone for a minimum of 2 weeks before enrollment.
- Patients with ability to complete various questionnaires.
- Patients and/or their legal guardians/representatives who sufficiently understand the objective of the study and sign informed consent form
Exclusion
- Active psychotic symptoms, including severe behavioral disturbance
- Relevant history of or current presence of any significant or unstable medical disease
- A woman who is pregnant, breast-feeding or planning to become pregnant during the study period
- Patients with the history of serious allergy or multiple adverse drug reactions
- Patients with the history of taking paliperidone ER within 60 days
- Patients with history of taking clozapine within 60 days
- Patients who require the treatment of other medications influencing CNS, except permitted concomitant drugs in advance
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00827840
Start Date
November 1 2008
End Date
February 1 2011
Last Update
December 23 2011
Active Locations (1)
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1
Dept. of Psychiatry, Chonnam National Univeristy Hospital
Gwangju, South Korea, 501-757