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The Safety and Tolerability Profile of Vilazodone, A Novel Antidepressant for the Treatment of Major Depressive Disorder.

Psychopharmacol Bull

September 2011

Dr. Liebowitz, MD, Affiliated with The Medical Research Network, LLC, New York, NY. Dr. Croft, MD, Affiliated with San Antonio Psychiatric Research Center, San Antonio, TX. Dr. Kajdasz, PhD and Ms. Whalen, MHS, Affiliated with Dogwood Pharmaceuticals, A Subsidiary of Forest Laboratories, Inc., New Haven, CT. Ms. Gallipoli, MSN, Former Full-Time Employee of Dogwood Pharmaceuticals, A Subsidiary of Forest Laboratories, Inc., New Haven, CT. Dr. Athanasiou, PhD, Affiliated with Athanasiou Consulting, LLC, Fond du Lac, WI. Dr. Reed, MD, Consultant to Forest Laboratories, Inc., New York, NY.

Objective: Vilazodone is a selective serotonin reuptake inhibitor and 5-HT receptor partial agonist approved for the treatment of major depressive disorder (MDD). This report summarizes the safety and tolerability of vilazodone 40 mg/day during short- and long-term treatment of adult MDD.

Methods: Pooled data from two 8-week, double-blind studies of vilazodone (n = 436) vs placebo (n = 433) and data from one 52-week, open-label study (n = 616, vilazodone only) were analyzed.

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