PMID- 27738360
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20191120
IS  - 0048-5764 (Print)
IS  - 2472-2448 (Electronic)
IS  - 0048-5764 (Linking)
VI  - 44
IP  - 3
DP  - 2011 Sep 15
TI  - The Safety and Tolerability Profile of Vilazodone, A Novel Antidepressant for the 
      Treatment of Major Depressive Disorder.
PG  - 15-33
AB  - OBJECTIVE: Vilazodone is a selective serotonin reuptake inhibitor and 5-HT(1A) 
      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. 
      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. RESULTS: 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. CONCLUSION: 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.
FAU - Liebowitz, Michael
AU  - Liebowitz M
AD  - 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.
FAU - Croft, Harry A
AU  - Croft HA
AD  - 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.
FAU - Kajdasz, Daniel K
AU  - Kajdasz DK
AD  - 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.
FAU - Whalen, Heidi
AU  - Whalen H
AD  - 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.
FAU - Gallipoli, Susan
AU  - Gallipoli S
AD  - 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.
FAU - Athanasiou, Maria
AU  - Athanasiou M
AD  - 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.
FAU - Reed, Carol R
AU  - Reed CR
AD  - 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.
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Psychopharmacol Bull
JT  - Psychopharmacology bulletin
JID - 0101123
PMC - PMC5044546
OTO - NOTNLM
OT  - adverse event
OT  - antidepressant tolerability
OT  - antidepressant-induced suicidality
OT  - sexual side effects
OT  - treatment emergent adverse event
OT  - weight gain
EDAT- 2011/09/15 00:00
MHDA- 2011/09/15 00:01
PMCR- 2011/09/15
CRDT- 2016/10/15 06:00
PHST- 2016/10/15 06:00 [entrez]
PHST- 2011/09/15 00:00 [pubmed]
PHST- 2011/09/15 00:01 [medline]
PHST- 2011/09/15 00:00 [pmc-release]
PST - ppublish
SO  - Psychopharmacol Bull. 2011 Sep 15;44(3):15-33.