PMID- 21869687
OWN - NLM
STAT- MEDLINE
DCOM- 20111227
LR  - 20221207
IS  - 1533-712X (Electronic)
IS  - 0271-0749 (Linking)
VI  - 31
IP  - 5
DP  - 2011 Oct
TI  - A 1-year, open-label study assessing the safety and tolerability of vilazodone in 
      patients with major depressive disorder.
PG  - 643-6
LID - 10.1097/JCP.0b013e31822c6741 [doi]
AB  - Vilazodone, a selective serotonin (5-HT) reuptake inhibitor and 5-HT(1A) receptor 
      partial agonist, was efficacious in two 8-week placebo-controlled studies in 
      adults with major depressive disorder. This open-label, multicenter study 
      assessed the long-term safety of vilazodone. Adult patients with a 17-item 
      Hamilton Rating Scale for Depression score of 18 or greater received vilazodone 
      according to a fixed-titration schedule to reach a dose of 40 mg/d continued up 
      to 1 year. Safety assessments included adverse events (AEs), physical 
      examinations, clinical chemistry, electrocardiograms, and the Changes in Sexual 
      Functioning Questionnaire. Effectiveness was assessed with the Montgomery-Asberg 
      Depression Rating Scale and Clinical Global Impressions scales. The safety 
      population comprised 599 patients; 254 patients completed 1 year of treatment. 
      The most frequent AEs were diarrhea (35.7%), nausea (31.6%), and headache 
      (20.0%); greater than 90% of these AEs were mild or moderate. Adverse events 
      resulting in discontinuation in more than 1% of patients were nausea (1.3%) and 
      diarrhea (1.2%). There were no clinically important changes in physical 
      examinations, electrocardiograms, or clinical chemistries. Mean weight increased 
      by 1.7 kg (observed cases). Changes in Sexual Functioning Questionnaire mean 
      scores (observed cases) improved throughout treatment for both males and females. 
      Montgomery-Asberg Depression Rating Scale mean scores were 29.9 at baseline, 11.4 
      at week 8, and 7.1 at week 52 (observed cases). Vilazodone 40 mg/d for 1 year was 
      safe and well tolerated by adults with major depressive disorder.
FAU - Robinson, Donald S
AU  - Robinson DS
AD  - Worldwide Drug Development, Burlington, VT, USA. dsrobmd@aol.com
FAU - Kajdasz, Daniel K
AU  - Kajdasz DK
FAU - Gallipoli, Susan
AU  - Gallipoli S
FAU - Whalen, Heidi
AU  - Whalen H
FAU - Wamil, Art
AU  - Wamil A
FAU - Reed, Carol R
AU  - Reed CR
LA  - eng
SI  - ClinicalTrials.gov/NCT00644358
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
RN  - 0 (Antidepressive Agents)
RN  - 0 (Benzofurans)
RN  - 0 (Indoles)
RN  - 0 (Piperazines)
RN  - 0 (Serotonin 5-HT1 Receptor Agonists)
RN  - 0 (Serotonin Uptake Inhibitors)
RN  - U8HTX2GK8J (Vilazodone Hydrochloride)
SB  - IM
MH  - Adult
MH  - Antidepressive Agents/adverse effects/therapeutic use
MH  - Benzofurans/adverse effects/*therapeutic use
MH  - Depressive Disorder, Major/*drug therapy
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Indoles/adverse effects/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Piperazines/adverse effects/*therapeutic use
MH  - Psychiatric Status Rating Scales
MH  - Serotonin 5-HT1 Receptor Agonists/adverse effects/therapeutic use
MH  - Selective Serotonin Reuptake Inhibitors/adverse effects/*therapeutic use
MH  - Treatment Outcome
MH  - Vilazodone Hydrochloride
EDAT- 2011/08/27 06:00
MHDA- 2011/12/28 06:00
CRDT- 2011/08/27 06:00
PHST- 2011/08/27 06:00 [entrez]
PHST- 2011/08/27 06:00 [pubmed]
PHST- 2011/12/28 06:00 [medline]
AID - 10.1097/JCP.0b013e31822c6741 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2011 Oct;31(5):643-6. doi: 10.1097/JCP.0b013e31822c6741.