Status:
COMPLETED
A Study to Compare the Effectiveness and Safety of Flexibly Varied Doses of Paliperidone Palmitate and Risperidone in Treating 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 study is to compare the effectiveness and safety over 1 year of treatment of intramuscular injections of paliperidone palmitate and long-acting risperidone in patients with schizop...
Detailed Description
Paliperidone palmitate is being developed as a long-acting intramuscular injectable formulation for the treatment of schizophrenia. Many patients with schizophrenia achieve symptom stability with the ...
Eligibility Criteria
Inclusion
- A diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated types) according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) for at least 1 year before the screening evaluation
- a total PANSS score of 60 to 120 at screening and baseline (pre-treatment) evaluations
- a body mass index (BMI \[weight (kilograms)\]/\[height (meters)\]²) of at least 15.0 kg/m² .
Exclusion
- A primary active DSM-IV Axis I diagnosis other than schizophrenia
- a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
- a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
- a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
- a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
748 Patients enrolled
Trial Details
Trial ID
NCT00210717
Start Date
February 1 2005
End Date
April 1 2007
Last Update
June 8 2011
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