Efficacy and safety of vilazodone 20 and 40 mg in major depressive disorder: a randomized, double-blind, placebo-controlled trial
Open accessAbstract
Vilazodone is a selective serotonin reuptake inhibitor and 5-HT1A partial agonist approved for major depressive disorder (MDD) treatment in adults. This was a 10-week, multicenter, double-blind, placebo-controlled and active-controlled, fixed-dose trial (NCT01473381). Adult patients with MDD (Diagnostic and Statistical Manual of Mental Disorders, 4th ed., text revision criteria) were randomized 1 : 1 : 1 : 1 to vilazodone 20 or 40 mg/day, citalopram 40 mg/day, or placebo. Primary efficacy: Montgomery-Åsberg Depression Rating Scale (MADRS); secondary efficacy: Clinical Global Impressions-Severity and sustained response (MADRS total score≤12 for at least the last two consecutive double-blind visits). The intent-to-treat population comprised 1133 patients, (placebo=281; vilazodone 20 mg/day=288; vilazodone 40 mg/day=284; citalopram=280). MADRS and Clinical Global Impressions-Severity score change from baseline to week 10 was significantly greater for vilazodone 20 mg/day, vilazodone 40 mg/day, and citalopram versus placebo. Sustained response rates were numerically higher, but not significantly different, in all active treatment groups versus placebo. The most common adverse events (≥5% of vilazodone patients, twice the rate of placebo) were diarrhea, nausea, vomiting (vilazodone 40 mg/day only), and insomnia. Improved sexual function (Changes in Sexual Functioning Questionnaire scores) was seen in all groups; between-group differences were not significant. Vilazodone 20 and 40 mg/day demonstrated efficacy and tolerability in the treatment of MDD.
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There was only one RCT which compared vilazodone with SSRIs (citalopram).
“In regards to vilazodone, there was only one RCT which compared it with SSRIs (citalopram).”
From Addressing the Side Effects of Contemporary Antidepressant Drugs: A Comprehensive Review (2018) · cites this paper as [96]
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- Authors
- Mathews, M., Gommoll, C., Chen, D., Nunez, R., & Khan, A.
- Affiliations
- Duke University (US)
- Forest Laboratories (United States) (US)
- Corresponding author
- Gommoll, Carl
- Venue
- International Clinical Psychopharmacology
- Published
- 2015-03
- Volume
- 30
- Issue
- 2
- Pages
- 67-74
- ISSN
- 0268-1315 (ISSN-L)
- PMC
- PMC4314105
- OpenAlex
- W2054030110
- Cited by
- 77
- References
- 21
- Citations by year
- 2026: 1 · 2025: 4 · 2024: 4 · 2023: 2 · 2022: 9 · 2021: 3 · 2020: 8 · 2019: 6 · 2018: 11 · 2017: 10 · 2016: 7 · 2015: 11 · 2014: 1
- FWCI
- 7.02
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-nd
- Locations
- International Clinical Psychopharmacology (publishedVersion, cc-by-nc-nd)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc-nd)
- PubMed Central (publishedVersion, cc-by-nc-nd)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Social Sciences › Psychology › Social Psychology › Mental Health Treatment and Access
- Keywords
- vilazodone, major depressive disorder, selective serotonin reuptake inhibitors, citalopram, antidepressant efficacy, antidepressant safety, sexual function, adverse events, sustained response
- MeSH terms
- Vilazodone Hydrochloride, Adolescent, Adult, Aged, Antidepressive Agents, Benzofurans, Major Depressive Disorder, Dose-Response Relationship, Drug, Double-Blind Method, Female, Humans, Indoles, Male, Middle Aged, Piperazines, Psychiatric Status Rating Scales, Citalopram, Treatment Outcome, Young Adult
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