Status:
COMPLETED
Trial Evaluating the Efficacy and Safety of 2 Fixed Doses of Paliperidone Extended-Release (ER) Tablets in the Treatment of Adult Patients 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 trial is to determine if paliperidone ER is an effective treatment for adults with schizophrenia.
Detailed Description
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relative...
Eligibility Criteria
Inclusion
- Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
- experiencing an acute episode, with a total PANSS score at screening between 70 and 120
- agree to voluntary hospitalization for a minimum of 14 days. Open-label phase: must have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy.
Exclusion
- DSM-IV axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- history of neuroleptic malignant syndrome (NMS)
- history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of lack of response to risperidone when acutely psychotic
- significant risk of suicidal or violent behavior.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2005
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00077714
Start Date
January 1 2004
End Date
January 1 2005
Last Update
June 8 2011
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