Status:
COMPLETED
A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.
Detailed Description
Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment. This trial is designed to evaluate efficacy and safety of palipe...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of schizophrenia at least 1 year before screening
- experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
- agree to be hospitalized for a minimum of 14 days at the start of the study
- capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
- resided at the same address continuously for at least 30 days prior to screening
- able and willing to fill out self administered questionnaires
- washout of antiparkinsonian medications, beta-blockers
- antiepileptics, lithium 3 days prior to the start of the run-in phase
Exclusion
- DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- previous history of lack of response to risperidone when acutely psychotic
- history of neuroleptic malignant syndrome
- significant risk of suicidal or violent behavior
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2005
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00086320
Start Date
March 1 2004
End Date
August 1 2005
Last Update
June 8 2011
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