Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia
Sponsor study identifier
interventional
203
0 countries
N/A
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
December 2005
Actual (reported)The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2005
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
September 13, 2005
Actual (reported)September 21, 2005
Actual (reported)December 2005
Actual (reported)Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
203 participants (actual enrollment reported by the registry).
First Submitted
September 13, 2005
First Posted
September 21, 2005
Study Start
January 2004
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Study Completion
December 2005
Actual (reported)Last Updated
May 18, 2011
Record last verified: 2010-04
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Source: ClinicalTrials.gov.
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