A randomized, double-blind, placebo-controlled 6-wk trial of the efficacy and tolerability of 5 mg vortioxetine in adults with major depressive disorder*
Open accessAbstract
Vortioxetine (Lu AA21004) is a multi-modal antidepressant in clinical development for the treatment of major depressive disorder (MDD). The current study evaluated the efficacy and tolerability of 5 mg vortioxetine compared to placebo after 6 wk of treatment in adults with MDD in an out-patient setting. Adults aged 18–75 yr, with a diagnosis of MDD and a baseline Montgomery–Asberg Depression Rating Scale (MADRS) total score ⩾30, were randomized to receive either 5 mg vortioxetine or placebo over 6 wk, followed by a 2-wk medication-free discontinuation period. The primary efficacy measure was change from baseline in Hamilton Rating Scale for Depression (HAMD)-24 total score at week 6 compared to placebo. Additional measures included response and remission rates, Clinical Global Impression Scale – Improvement scores, HAMD-24 total score in subjects with baseline Hamilton Anxiety Scale (HAMA) >19 and MADRS-S total score. Adverse events (AEs) were assessed throughout the study. A total of 600 adults were randomized. There were no significant differences in efficacy measures between subjects in the 5 mg vortioxetine and placebo groups at week 6. HAMD-24 total score in subjects with baseline HAMA >19 in the 5 mg vortioxetine group was improved at weeks 3–6 compared to the placebo group (nominal p value <0.05). The most common AEs for the vortioxetine and placebo groups were nausea (19.1 and 9.4%), headache (17.1 and 15.1%) and diarrhoea (11.4 and 7.0%), respectively. In this study of adults with MDD, 5 mg vortioxetine did not differ significantly from placebo in reducing depression symptoms after 6 wk of treatment.
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For comparison, ~25% of participants were excluded from two recent major depressive disorder (MDD) trials of the non-hallucinogenic compound vortioxetine.
“~25% of participants were excluded from two recent major depressive disorder (MDD) trials of the non-hallucinogenic compound vortioxetine”
From Psychedelics and Other Psychoplastogens for Treating Mental Illness. (2021) · cites this paper as [266]
Clinical studies in many countries have reported the clinical effects of Vortioxetine on cognitive function in patients with depression.
“Clinical studies in many countries have reported the clinical effects of Vortioxetine on cognitive function in patients with depression.15–18”
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Self-citationPharmacology and clinical potential of vortioxetine in the treatment of major depressive disorder
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- Authors
- Jain, R., Mahableshwarkar, A. R., Jacobsen, P. L., Chen, Y., & Thase, M. E.
- Affiliations
- The University of Texas Health Science Center at Houston (US)
- Takeda (United States) (US)
- University of Pennsylvania (US)
- Corresponding author
- Thase, Michael E.
- Venue
- International Journal of Neuropsychopharmacology
- Publisher
- Oxford University Press (OUP)
- Published
- 2012-09-11
- Volume
- 16
- Issue
- 2
- Pages
- 313-321
- ISSN
- 1461-1457 (ISSN-L)
- 1469-5111
- OpenAlex
- W2054766240
- Cited by
- 132
- References
- 8
- Citations by year
- 2026: 2 · 2025: 5 · 2024: 8 · 2023: 4 · 2022: 5 · 2021: 7 · 2020: 6 · 2019: 9 · 2018: 8 · 2017: 10 · 2016: 14 · 2015: 28 · 2014: 17 · 2013: 8 · 2012: 1
- FWCI
- 12.70
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- The International Journal of Neuropsychopharmacology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- American Psychiatric Foundation
- Bristol-Myers Squibb
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Takeda Pharmaceuticals U.S.A.
- Sunovion
- Shionogi
- H. Lundbeck A/S
- Agency for Healthcare Research and Quality
- National Institute of Mental Health
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Keywords
- vortioxetine, major depressive disorder, antidepressant efficacy, drug tolerability, placebo comparison, outpatient care, anxiety symptoms, adverse events, nausea, headache, diarrhea
- MeSH terms
- Vortioxetine, Adolescent, Adult, Aged, Antidepressive Agents, Major Depressive Disorder, Depressive Disorder, Major, Double-Blind Method, Female, Follow-Up Studies, Humans, Male, Middle Aged, Piperazines, Psychiatric Status Rating Scales, Sulfides, United States, Young Adult
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