Status:
COMPLETED
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily...
Detailed Description
The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with...
Eligibility Criteria
Inclusion
- As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
- completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
- for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.
Exclusion
- As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
- a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
- considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
- received an injection of a depot antipsychotic since entry into the double-blind study
- a woman who has become pregnant.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT00210769
Start Date
January 1 2004
End Date
December 1 2005
Last Update
May 18 2011
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