Status:
COMPLETED
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
Lead Sponsor:
Janssen Pharmaceutical K.K.
Conditions:
Schizophrenia
Eligibility:
All Genders
20-64 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophreni...
Detailed Description
Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-g...
Eligibility Criteria
Inclusion
- Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
- taking not more than one oral antipsychotic medication within 28 days of study entry
- a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia
Exclusion
- Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
- history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
- drug allergy or hypersensitivity to antipsychotics
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2005
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00257023
Start Date
February 1 2005
End Date
September 1 2005
Last Update
May 17 2011
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