Efficacy and tolerability of controlled-release paroxetine in the treatment of severe depression: post hoc analysis of pooled data from a subset of subjects in four double-blind clinical trials

Clinical Therapeutics
D L DunnerJohn T Davies

Abstract

The aims of this work were to assess the efficacy and tolerability of controlled-release paroxetine (paroxetine CR) in the treatment of outpatients with severe major depressive disorder (MDD). This was a retrospective analysis of pooled data from 4 previously published, double-blind, randomized, placebo-controlled, 8- to 12-week outpatient studies of paroxetine CR (12.5-62.5 mg) in MDD. However, the studies were designed to assess the efficacy of paroxetine CR overall, rather than specifically in those with severe MDD. Subjects were categorized according to their baseline mean 17-item Hamilton Depression Rating Scale (HAMD-17) total score as having severe (> or =25) or nonsevere (<25) depression. Changes in depressive symptomatology were assessed, based on the mean change from baseline in HAMD-17 total scores and the proportion of responders (> or =50% reduction from baseline in HAMD-17 total scores or Clinical Global Impression [CGI] of Improvement scores of 1 or 2), for each study and pooled across the studies. The pooled analysis of data also assessed the proportion of patients achieving remission (HAMD-17 total score < or =7 or CGI-Improvement score of 1) at last-observation-carried-forward end point. A total of 1083 subjec...Continue Reading

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Citations

Mar 4, 2009·European Archives of Psychiatry and Clinical Neuroscience·Andreas B SchmittPeter-Andreas Loeschmann
Feb 17, 2010·The Consultant Pharmacist : the Journal of the American Society of Consultant Pharmacists·Michael NamakaHoward Intrater
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Mar 29, 2019·The Journal of Nervous and Mental Disease·Mark Zimmerman
Mar 27, 2021·Development and Psychopathology·Peter FonagyPatrick Luyten

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