Status:
COMPLETED
Safety Study With Paliperidone ER Extended-Release (ER) Tablets in Geriatric Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief Summary
The primary objective of the study is to evaluate the safety and tolerability of flexible dosages of paliperidone ER as compared with placebo in patients with schizophrenia who are 65 years of age or ...
Detailed Description
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The ER formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate ov...
Eligibility Criteria
Inclusion
- Double-Blind Phase: 65 years of age or older
- DSM-IV diagnosis of schizophrenia for at least 1 year
- total PANSS score at screening and baseline between 70 and 120, inclusive
- agrees to hospitalization for a minimum of 14 days and for the duration of the study, if clinically indicated
- Open-label treatment phase: completed 6 weeks of the double-blind treatment phase or finished at least 21 days of treatment and discontinued because of lack of efficacy.
Exclusion
- DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within the 6 months before screening (nicotine and caffeine dependence are not exclusionary)
- history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
- history of any severe preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of a lack of response (2 adequate trials) to any antipsychotic
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT00085748
Start Date
August 1 2004
End Date
May 1 2005
Last Update
June 8 2011
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