A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia
Sponsor study identifier
interventional
399
0 countries
N/A
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
September 2007
Actual (reported)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 who are acutely ill with symptoms of schizophrenia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2007
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
June 2, 2006
Actual (reported)June 6, 2006
Actual (reported)September 2007
Actual (reported)Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14
Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Canuso CM, Dirks B, Carothers J, Kosik-Gonzalez C, Bossie CA, Zhu Y, Damaraju CV, Kalali AH, Mahmoud R. Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry. 2009 Jun;166(6):691-701. doi: 10.1176/appi.ajp.2009.08040613. Epub 2009 May 1.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
399 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2006
First Posted
June 6, 2006
Study Start
April 2006
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
September 2007
Actual (reported)Last Updated
May 18, 2011
Record last verified: 2010-03
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Source: ClinicalTrials.gov.
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