A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
Alvarez, Enric (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Pérez Solà, Víctor (Centro de Investigación Biomédica en Red de Salud Mental)
Dragheim, Marianne (H. Lundbeck A/S, Copenhagen, Denmark)
Loft, Henrik (H. Lundbeck A/S, Copenhagen, Denmark)
Artigas Pérez, Francesc (Institut d'Investigacions Biomèdiques de Barcelona)

Date:	2011
Abstract:	The efficacy, safety, and tolerability of Lu AA21004 vs. placebo using venlafaxine XR as active reference in patients with DSM-IV-TR major depressive disorder (MDD) were evaluated. Lu AA21004 is a novel antidepressant that is a 5-HT and 5-HT receptor antagonist, 5-HT receptor agonist, 5-HT receptor partial agonist and inhibitor of the 5-HT transporter in recombinant cell lines. In this 6-wk, multi-site study, 429 patients were randomly assigned (1:1:1:1) to 5 or 10 mg Lu AA21004, placebo or 225 mg venlafaxine XR. All patients had a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score ⩾30. The primary efficacy analysis was based on the MADRS total score adjusting for multiplicity using a hierarchical testing procedure starting with the highest dose vs. placebo. Lu AA21004 was statistically significantly superior to placebo (n =105) in mean change from baseline in MADRS total score at week 6 (p <0. 0001, last observation carried forward), with a mean treatment difference vs. placebo of 5. 9 (5 mg, n =108), and 5. 7 (10 mg, n =100) points. Venlafaxine XR (n =112) was also significantly superior to placebo at week 6 (p <0. 0001). In total, 30 patients withdrew due to adverse events (AEs) - placebo: four (4%); 5 mg Lu AA21004: three (3%); 10 mg Lu AA21004: seven (7%); and venlafaxine: 16 (14%). The most common AEs were nausea, headache, hyperhidrosis, and dry mouth. No clinically relevant changes over time were seen in the clinical laboratory results, vital signs, weight, or ECG parameters. In this study, treatment with 5 mg and 10 mg Lu AA21004 for 6 wk was efficacious and well tolerated in patients with MDD.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Depression ; Lu AA21004 ; MADRS ; Serotonin receptor affinity ; Venlafaxine
Published in:	International journal of neuropsychopharmacology, Vol. 15 (july 2011) , p. 589-600, ISSN 1469-5111

DOI: 10.1017/S1461145711001027
PMID: 21767441

12 p, 168.5 KB

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