A randomized, double-blind, placebo-controlled, duloxetine-referenced, fixed-dose study comparing the efficacy and safety of Lu AA21004 in elderly patients with major depressive disorder

International Clinical Psychopharmacology
Cornelius KatonaChristina Kurre Olsen

Abstract

The efficacy and tolerability of Lu AA21004 at 5 mg/day, a novel multimodal antidepressant, were assessed in elderly patients with recurrent major depressive disorder. Patients were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60 mg/day (reference) or to placebo in an 8-week double-blind study. The primary efficacy measure was the 24-item Hamilton Depression Scale (HAM-D(24)) total score (analysis of covariance, last observation carried forward). Patients (mean age 70.6 years) had a mean baseline HAM-D(24) score of 29.0. Lu AA21004 showed significantly (P = 0.0011) greater improvement on the primary efficacy endpoint compared with placebo at week 8 (3.3 points). Duloxetine also showed superiority to placebo at week 8, thereby validating the study. HAM-D(24) response (53.2 vs. 35.2%) and HAM-D(17) remission (29.2 vs. 19.3%) rates at endpoint were higher for Lu AA21004 than for placebo. Lu AA21004 showed superiority to placebo in cognition tests of speed of processing, verbal learning and memory. The withdrawal rate due to adverse events was 5.8% (Lu AA21004), 9.9% (duloxetine) and 2.8% (placebo). Whereas nausea was the only adverse event with a significantly higher incidence on treatment with Lu AA21004 (21.8%) c...Continue Reading

Citations

Dec 7, 2013·Drugs·Andrew Gibb, Emma D Deeks
Aug 26, 2014·CNS Drugs·Karly P Garnock-Jones
Dec 18, 2013·Drug Safety : an International Journal of Medical Toxicology and Drug Experience·Ursula ReichenpfaderBradley N Gaynes
Dec 19, 2015·Expert Opinion on Pharmacotherapy·K Ryan Connolly, Michael E Thase
Aug 29, 2014·Expert Review of Clinical Pharmacology·Laurent TritschlerDenis Joseph David
Apr 18, 2014·Expert Review of Neurotherapeutics·Rajnish MagoChittaranjan Andrade
Sep 17, 2014·Expert Opinion on Pharmacotherapy·William James Deardorff, George T Grossberg
Apr 2, 2014·Expert Opinion on Drug Metabolism & Toxicology·Steven L Dubovsky
Dec 23, 2014·Expert Opinion on Investigational Drugs·Sheng-Min WangChi-Un Pae
Mar 5, 2015·Expert Opinion on Drug Metabolism & Toxicology·Janet SultanaGianluca Trifirò
Feb 19, 2016·Accountability in Research·Lisa CosgroveAllen F Shaughnessy
Jan 24, 2016·BMC Medicine·Beatrice BortolatoAndré F Carvalho
Mar 8, 2016·Progress in Neuro-psychopharmacology & Biological Psychiatry·Gennady N SmaginConnie Sánchez
Jul 13, 2014·Pharmacology & Therapeutics·Connie SanchezFrancesc Artigas
Oct 31, 2015·Schizophrenia Research·Nils Eiel SteenOle A Andreassen
Feb 13, 2014·Human Psychopharmacology·Bethan Impey, David S Baldwin
May 4, 2016·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Michael E ThaseEduard Vieta
Nov 29, 2013·European Neuropsychopharmacology : the Journal of the European College of Neuropsychopharmacology·Jesper Bornø JensenAlan Lars Pehrson
Mar 12, 2016·Drug and Therapeutics Bulletin
Apr 5, 2016·Annals of the New York Academy of Sciences·Annette B Brühl, Barbara J Sahakian
Sep 24, 2015·Annals of General Psychiatry·Xenia GondaPeter Dome
Nov 4, 2015·Basic & Clinical Pharmacology & Toxicology·Himanshu NaikJohan Areberg
Feb 7, 2015·Annals of the New York Academy of Sciences·Sarah Shizuko MorimotoGeorge S Alexopoulos
Mar 13, 2015·Annals of the New York Academy of Sciences·Alan F Schatzberg

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