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Efficacy and safety of vortioxetine (Lu AA21004), 15 and 20 mg/day: a randomized, double-blind, placebo-controlled, duloxetine-referenced study in the acute treatment of adult patients with major depressive disorder
- Source :
- International Clinical Psychopharmacology
- Publication Year :
- 2013
-
Abstract
- This study assessed the efficacy, tolerability and safety of vortioxetine versus placebo in adults with recurrent major depressive disorder. This double-blind, randomized, placebo-controlled study included 608 patients [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 26 and Clinical Global Impression - Severity score ≥ 4]. Patients were randomly assigned (1 : 1 : 1 : 1) to vortioxetine 15 mg/day, vortioxetine 20 mg/day, duloxetine 60 mg/day or placebo. The primary efficacy endpoint was change from baseline in MADRS total score at week 8 (mixed model for repeated measurements). Key secondary endpoints were: MADRS responders; Clinical Global Impression - Improvement scale score; MADRS total score in patients with baseline Hamilton Anxiety Rating Scale ≥ 20; remission (MADRS ≤ 10); and Sheehan Disability Scale total score at week 8. On the primary efficacy endpoint, both vortioxetine doses were statistically significantly superior to placebo, with a mean difference to placebo (n = 158) of -5.5 (vortioxetine 15 mg, P0.0001, n = 149) and -7.1 MADRS points (vortioxetine 20 mg, P0.0001, n = 151). Duloxetine (n = 146) separated from placebo, thus validating the study. In all key secondary analyses, both vortioxetine doses were statistically significantly superior to placebo. Vortioxetine treatment was well tolerated; common adverse events (incidence ≥ 5%) were nausea, headache, diarrhea, dry mouth and dizziness. No clinically relevant changes were seen in clinical safety laboratory values, weight, ECG or vital signs parameters. Vortioxetine was efficacious and well tolerated in the treatment of patients with major depressive disorder.
- Subjects :
- Adult
Male
Internationality
Hamilton Anxiety Rating Scale
Adolescent
Thiophenes
Sulfides
Placebo
Duloxetine Hydrochloride
vortioxetine
Piperazines
law.invention
chemistry.chemical_compound
Young Adult
Randomized controlled trial
Double-Blind Method
Montgomery–Åsberg Depression Rating Scale
law
Duloxetine
Humans
Pharmacology (medical)
Sheehan Disability Scale
Aged
Vortioxetine
Psychiatric Status Rating Scales
Depressive Disorder, Major
recurrent major depressive disorder
duloxetine
Headache
Nausea
Original Articles
Middle Aged
Psychiatry and Mental health
Treatment Outcome
chemistry
Tolerability
Anesthesia
Clinical Global Impression
placebo controlled
Female
Psychology
Levomilnacipran
Selective Serotonin Reuptake Inhibitors
Subjects
Details
- ISSN :
- 14735857
- Volume :
- 29
- Issue :
- 3
- Database :
- OpenAIRE
- Journal :
- International clinical psychopharmacology
- Accession number :
- edsair.doi.dedup.....ec0e64cc22645237344554b12a46a1e2