Status:
COMPLETED
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
Janssen, LP
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients ...
Detailed Description
This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage),...
Eligibility Criteria
Inclusion
- Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)
- score of \>=4 on at least two of a subset of selected PANSS items and a total score on these five items of \>=17
- score of \>=5 on the CGI-S (clinical global impression - severity)
- body weight of at least 60kg and willing to be hospitalized for 9 days initially
Exclusion
- A primary active mental illness diagnosis other than schizophrenia
- subjects whose psychotic symptoms can be explained by substance intake or medical illness
- pregnancy, breast-feeding, or planning to become pregnant
- a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)
- unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT00334126
Start Date
April 1 2006
End Date
September 1 2007
Last Update
May 18 2011
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