A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
| Autor: | Marianne Dragheim, Enric Álvarez, Henrik Loft, Francesc Artigas, Víctor Pérez |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2011 |
| Předmět: |
Adult
Male medicine.medical_specialty MADRS Venlafaxine Hydrochloride Venlafaxine Sulfides Placebo Partial agonist Gastroenterology Piperazines Placebos Double-Blind Method Serotonin receptor affinity venlafaxine Internal medicine serotonin receptor affinity medicine Humans Pharmacology (medical) Psychiatry Pharmacology Vortioxetine Psychiatric Status Rating Scales Depressive Disorder Major Depression Lu AA21004 Middle Aged medicine.disease Cyclohexanols Diagnostic and Statistical Manual of Mental Disorders Psychiatry and Mental health Treatment Outcome Tolerability Receptor Serotonin 5-HT1A Major depressive disorder Antidepressive Agents Second-Generation Female Psychology Levomilnacipran medicine.drug Research Article |
| Zdroj: | The International Journal of Neuropsychopharmacology Digital.CSIC. Repositorio Institucional del CSIC instname INTERNATIONAL JOURNAL OF NEUROPSYCHOPHARMACOLOGY r-IIB SANT PAU. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica Sant Pau Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona |
| ISSN: | 1469-5111 1461-1457 |
| Popis: | 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-HT3 and 5-HT7 receptor antagonist, 5-HT1A receptor agonist, 5-HT1B 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 This study was sponsored by H. Lundbeck A/S. |
| Databáze: | OpenAIRE |
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