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Vilazodone for the treatment of depression.

AbstractOBJECTIVE:
To evaluate the clinical literature on and potential clinical role of vilazodone for the treatment of major depressive disorder.
DATA SOURCES:
Searches were conducted on MEDLINE (1948-February 2011), Iowa Drug Information Service (1988-February 2011), EBSCO Academic Search Premier (1975-February 2011), Google Scholar (1992-February 2011), PsycINFO (1980-February 2011), and PsycARTICLES (1985-February 2011), and on general Internet search engines including Google and Bing (no lower limit-February 2011). Search terms were vilazodone, EMD 68843, depression, and major depressive disorder. Potential prior marketers of vilazodone, including Merck KGaA in Germany and Genaissance Pharmaceuticals, were contacted for any available unpublished Phase 1, Phase 2, Phase 3 studies, or preclinical information.
STUDY SELECTION AND DATA EXTRACTION:
All applicable full-text English-language articles, abstracts, and professional poster presentations found were evaluated and included in the review, as well as marketing and Securities and Exchange Commission filings available from the patent holders.
DATA SYNTHESIS:
Vilazodone is an antidepressant recently approved by the Food and Drug Administration (FDA) that is first in a new class regarding mechanism of action. It has demonstrated efficacy in the primary outcome of the Montgomery-Asberg Depression Rating Scale (MADRS) response in an 8-week pivotal Phase 3 trial. Phase 2 trials did not demonstrate efficacy for primary outcomes of the 17-item Hamilton Rating Scale for Depression but showed statistically significant improvements in select secondary outcomes such as Clinical Global Impressions severity and MADRS. Long-term efficacy data are still forthcoming. An emerging aspect to vilazodone's development has been the identification and assessment of potential genetic biomarkers associated with both therapeutic response and more serious adverse effects. Initial studies into biomarkers have been inconclusive.
CONCLUSIONS:
Vilazodone is a new agent recently approved by the FDA for treating major depressive disorder. Response rates seen with vilazodone are similar to those of currently available antidepressants.
AuthorsWesley T Lindsey
JournalThe Annals of pharmacotherapy (Ann Pharmacother) Vol. 45 Issue 7-8 Pg. 946-53 (Jul 2011) ISSN: 1542-6270 [Electronic] United States
PMID21672888 (Publication Type: Journal Article, Review)
Chemical References
  • Antidepressive Agents
  • Benzofurans
  • Genetic Markers
  • Indoles
  • Piperazines
  • Serotonin 5-HT1 Receptor Agonists
  • Serotonin Uptake Inhibitors
  • Receptor, Serotonin, 5-HT1A
  • Vilazodone Hydrochloride
Topics
  • Adult
  • Animals
  • Antidepressive Agents (adverse effects, pharmacokinetics, therapeutic use)
  • Benzofurans (adverse effects, pharmacokinetics, therapeutic use)
  • Depressive Disorder, Major (drug therapy, metabolism)
  • Genetic Markers
  • Humans
  • Indoles (adverse effects, pharmacokinetics, therapeutic use)
  • Piperazines (adverse effects, pharmacokinetics, therapeutic use)
  • Receptor, Serotonin, 5-HT1A (chemistry)
  • Serotonin 5-HT1 Receptor Agonists (adverse effects, pharmacokinetics, therapeutic use)
  • Serotonin Uptake Inhibitors (adverse effects, pharmacokinetics, therapeutic use)
  • Vilazodone Hydrochloride

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