Vilazodone: In Major Depressive Disorder
CNS Drugs, 07/31/2011 Clinical Article
Frampton JE – Vilazodone was generally well tolerated in the short– and long–term treatment of major depressive disorder (MDD), with diarrhoea and nausea being the most frequently occurring treatment–emergent adverse events. Vilazodone had a minimal impact on sexual functioning in the three phase III studies.
Vilazodone, a novel antidepressant agent that combines selective serotonin reuptake inhibitor (SSRI) activity and serotonin 5–HT1A receptor partial agonist activity in a
single molecule, is indicated for the treatment of major depressive disorder (MDD) in the US.
It is administered orally, once daily, with food.
At the recommended dosage of 40 mg/day, vilazodone was effective in the short–term treatment of MDD in adults, as evidenced by significant improvements versus placebo on multiple measures of depression, including the Montgomery–Åsberg Depression Rating Scale (MADRS) and the 17–item Hamilton Rating Scale for Depression (HAM–D–17), in two pivotal, 8–week, randomized, double–blind, phase III studies.
Significant differences between vilazodone and placebo on the MADRS and HAM–D–17 were seen after 1 week of treatment (first efficacy timepoint) in one of the two studies.
Long–term treatment with vilazodone 40 mg/day was associated with an improvement from baseline in depressive symptoms in a 52–week, noncompar–ative, phase III study