Efficacy and tolerability of vilazodone for major depressive disorder: Evidence from phase III/IV randomized controlled trials
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Abstract: Vilazodone is a new molecule approved for major depressive disorder (MDD). This report focuses on the efficacy and tolerability of vilazodone for MDD. MEDLINE, EMBASE, and Cochrane Library were searched. A total of 1,930 patients from four trials were included. A significant improvement in the Montgomery–Asberg Depression Rating Scale (MADRS) total score was seen as early as week 2 ( P <0.01) in vilazodone-treated patients. The results showed a higher rate of MADRS response with vilazodone compared with placebo ( P <0.001). There were also greater improvements in the Hamilton Rating Scale for Anxiety as well as the Clinical Global Impressions (severity of illness and improvement of illness) scores from baseline in vilazodone-treated patients compared to placebo patients ( P <0.001). Discontinuation rates due to adverse events were higher with vilazodone than placebo ( P =0.0002). The most common adverse events of vilazodone were vomiting, nausea, diarrhea, insomnia, somnolence, dizziness, and dry mouth ( P <0.05). Treatment-related effects on sexual function were mild compared to placebo in men ( P =0.03). In conclusion, 40 mg/day of vilazodone had a rapid onset of response and showed good improvement in anxiety symptoms as well as good tolerability during short-term treatment (8–10 weeks) for MDD. Further studies should focus on the efficacy and tolerability of vilazodone over a longer duration and should utilize active comparators. Keywords: vilazodone, major depressive disorder, sexual dysfunction, anxiety
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This observation is in contrast to evidence derived from patients with depression, where good tolerability of vilazodone was reported.
“This observation is in contrast to evidence derived from patients with depression, where good tolerability of vilazodone was reported (Shi et al., 2016).”
From Novel pharmacological targets in drug development for the treatment of anxiety and anxiety-related disorders (2019) · cites this paper as Shi et al., 2016
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References 37 · Cited by 13
- Authors
- Shi, L., Wang, J., Xu, S., & Lu, Y.
- Affiliations
- Second Affiliated Hospital of Zhejiang University (CN)
- Zhejiang University (CN)
- Venue
- Drug Design Development and Therapy
- Publisher
- Informa UK Limited
- Published
- 2016-11
- Volume
- Volume 10
- Pages
- 3899-3907
- ISSN
- 1177-8881 (ISSN-L)
- PMC
- PMC5135073
- OpenAlex
- W2550614139
- Cited by
- 13
- References
- 37
- Citations by year
- 2026: 1 · 2024: 2 · 2023: 2 · 2022: 2 · 2020: 1 · 2019: 4 · 2018: 1
- FWCI
- 1.35
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- Drug Design Development and Therapy (publishedVersion, cc-by-nc)
- Europe PMC (PubMed Central) (publishedVersion, cc-by-nc)
- PubMed Central (publishedVersion, cc-by-nc)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Dove Medical Press (Taylor and Francis Group) (submittedVersion, cc-by-nc)
- Funders
- Medical Science and Technology Project of Zhejiang Province
- Science and Technology Program of Zhejiang Province
- 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, antidepressant efficacy, drug tolerability, adverse events, sexual dysfunction, anxiety symptoms, serotonin reuptake inhibitors, placebo comparison
- MeSH terms
- Vilazodone Hydrochloride, Major Depressive Disorder, Double-Blind Method, Drug Tolerance, Humans, Randomized Controlled Trials as Topic, Clinical Trials, Phase III as Topic, Clinical Trials, Phase IV as Topic
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