title: The Safety and Tolerability Profile of Vilazodone, A Novel Antidepressant for the Treatment of Major Depressive Disorder.
abstract: Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1Areceptor 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.
  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. Patients aged 18-70 with DSM-IV-TR-defined MDD received vilazodone or placebo (8-week studies only) once daily, with food, titrated to 40 mg/day over 2 weeks. Safety and tolerability assessments included adverse events (AEs), laboratory tests, vital signs, electrocardiograms, and weight.
  The most common AEs in all studies were diarrhea, nausea, and headache. Vilazodone-associated AEs in the two 8-week studies, defined as an incidence rate of ≥5% in the vilazodone group and at least twice that for placebo, were diarrhea (28.0% vs 9.2%), nausea (23.4% vs 5.1%), and insomnia (6.0% vs 2.1%), with the majority reported as mild to moderate and <5% of those patients requiring concomitant (directed) treatment for these conditions. Discontinuation rates due to AEs were 7.1% (vilazodone) and 3.2% (placebo) in the 8-week studies and 20.7% in the 52-week study. Vilazodone had no clinically significant effects on vital signs, laboratory tests, or electrocardiograms.
  Vilazodone 40 mg/day was well tolerated during short- and long-term MDD treatment in these trials. Safety profiles associated with 8- and 52-week exposure were consistent.
authors.affiliation: 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.
authors.forename: Michael
authors.initials: M
authors.lastname: Liebowitz
authors.affiliation: 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.
authors.forename: Harry A
authors.initials: HA
authors.lastname: Croft
authors.affiliation: 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.
authors.forename: Daniel K
authors.initials: DK
authors.lastname: Kajdasz
authors.affiliation: 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.
authors.forename: Heidi
authors.initials: H
authors.lastname: Whalen
authors.affiliation: 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.
authors.forename: Susan
authors.initials: S
authors.lastname: Gallipoli
authors.affiliation: 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.
authors.forename: Maria
authors.initials: M
authors.lastname: Athanasiou
authors.affiliation: 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.
authors.forename: Carol R
authors.initials: CR
authors.lastname: Reed
keywords: adverse event; antidepressant tolerability; antidepressant-induced suicidality; sexual side effects; treatment emergent adverse event; weight gain