A double-blind, randomized, placebo-controlled, active reference study of Lu AA21004 in patients with major depressive disorder
Open accessAbstract
The efficacy, safety, and tolerability of Lu AA21004 vs. placebo using venlafaxine XR as active reference in patients with DSM-IV-TR major depressive disorder (MDD) were evaluated. Lu AA21004 is a novel antidepressant that is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1A receptor agonist, 5-HT1B receptor partial agonist and inhibitor of the 5-HT transporter in recombinant cell lines. In this 6-wk, multi-site study, 429 patients were randomly assigned (1:1:1:1) to 5 or 10 mg Lu AA21004, placebo or 225 mg venlafaxine XR. All patients had a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 30. The primary efficacy analysis was based on the MADRS total score adjusting for multiplicity using a hierarchical testing procedure starting with the highest dose vs. placebo. Lu AA21004 was statistically significantly superior to placebo (n=105) in mean change from baseline in MADRS total score at week 6 (p<0.0001, last observation carried forward), with a mean treatment difference vs. placebo of 5.9 (5 mg, n=108), and 5.7 (10 mg, n=100) points. Venlafaxine XR (n=112) was also significantly superior to placebo at week 6 (p<0.0001). In total, 30 patients withdrew due to adverse events (AEs)--placebo: four (4%); 5 mg Lu AA21004: three (3%); 10 mg Lu AA21004: seven (7%); and venlafaxine: 16 (14%). The most common AEs were nausea, headache, hyperhidrosis, and dry mouth. No clinically relevant changes over time were seen in the clinical laboratory results, vital signs, weight, or ECG parameters. In this study, treatment with 5 mg and 10 mg Lu AA21004 for 6 wk was efficacious and well tolerated in patients with MDD.
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The incidence rate of adverse events is similar to that of previous clinical studies at around 30%.
“The incidence rate is similar to that of previous clinical studies at around 30%.17,34”
From A Randomized Controlled Study of Efficacy and Cognitive Function Improvement of Vortioxetine and Escitalopram in Patients with Depression in Chinese Han Nationality (2024) · cites this paper as [34]
The AEs section reports that 61%–75% of patients across treatment groups experienced at least one adverse event during the six-week treatment period, not around 30%. The paper does not establish the claimed similarity to previous studies. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measuredVortioxetine has demonstrated efficacy in doses up to 20 mg/d in short-term studies of 6-8 wk duration in adult patients with MDD.
“Vortioxetine (1-[2-(2,4-dimethyl-phenylsulfanyl)-phenyl]-piperazine-hydrobromide, Lu AA21004) is a novel antidepressant that has demonstrated efficacy in doses up to 20 mg/d in short-term studies of 6–8 wk duration in adult patients with MDD (Alvarez et al., 2012; Henigsberg et al., 2012; Boulenger et al., 2014).”
From A randomized, double-blind, placebo-controlled study of vortioxetine on cognitive function in depressed adults (2014) · cites this paper as Alvarez et al., 2012
The Introduction and Discussion report efficacy of 5 and 10 mg/day Lu AA21004 after six weeks in adults with MDD. This study did not test 20 mg/day, so it supports the short-term efficacy claim but not the stated upper dose. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThere has been a tendency across studies to see increasing efficacy at higher doses of vortioxetine.
“there has been a tendency across studies to see increasing efficacy at higher doses”
From A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD (2015) · cites this paper as Alvarez et al. 2012
Efficacy of vortioxetine has been replicated at the 5-, 10-, and 20-mg doses in adults.
“Efficacy has been replicated at the 5-, 10-, and 20-mg doses in adults”
From A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD (2015) · cites this paper as Alvarez et al. 2012
The efficacy of vortioxetine in reducing depressive symptoms has been demonstrated in patients with MDD in doses from 5 to 20 mg/day.
“The efficacy of vortioxetine in reducing depressive symptoms has been demonstrated in patients with MDD in doses from 5 to 20 mg/day (Alvarez et al. 2012;Katona et al. 2012;Henigsberg et al. 2012;Baldwin et al. 2012a;Boulenger et al. 2012;Baldwin et al. 2012b;Jacobsen et al. 2013;Boulenger et al. 2014;Jain et al. 2013;Mahableshwarkar et al. 2013b).”
From A randomized, double-blind, duloxetine-referenced study comparing efficacy and tolerability of 2 fixed doses of vortioxetine in the acute treatment of adults with MDD (2015) · cites this paper as Alvarez et al. 2012
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- Authors
- Alvarez, E., Perez, V., Dragheim, M., Loft, H., & Artigas, F.
- Affiliations
- Lundbeck (Denmark) (DK)
- Consejo Superior de Investigaciones Científicas (ES)
- Corresponding author
- Dragheim, Marianne
- ORCID
- Artigas, Francesc
- Venue
- The International Journal of Neuropsychopharmacology
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-07-18
- Volume
- 15
- Issue
- 05
- Pages
- 589-600
- ISSN
- 1461-1457 (ISSN-L)
- 1469-5111
- PMC
- PMC3349292
- OpenAlex
- W2048026164
- Cited by
- 225
- References
- 31
- Citations by year
- 2026: 4 · 2025: 7 · 2024: 14 · 2023: 9 · 2022: 13 · 2021: 11 · 2020: 9 · 2019: 15 · 2018: 13 · 2017: 17 · 2016: 20 · 2015: 33 · 2014: 27 · 2013: 19 · 2012: 11
- FWCI
- 13.82
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- cc-by-nc-sa
- Locations
- The International Journal of Neuropsychopharmacology (publishedVersion, cc-by-nc-sa)
- PubMed Central (publishedVersion, cc-by-nc-sa)
- PubMed (publishedVersion)
- Dipòsit Digital de Documents de la UAB (Universitat Autònoma de Barcelona) (submittedVersion, cc-by-nc)
- DIGITAL.CSIC (Spanish National Research Council (CSIC)) (submittedVersion, other-oa)
- Funders
- Eli Lilly and Company
- Pfizer
- AstraZeneca
- Sanofi
- Servier
- H. Lundbeck A/S
- Topics
- Health Sciences › Medicine › Pharmacology › Treatment of Major Depression
- Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
- Life Sciences › Neuroscience › Biological Psychiatry › Tryptophan and brain disorders
- Keywords
- vortioxetine, major depressive disorder, antidepressant efficacy, 5-HT3 receptor antagonists, 5-HT7 receptor antagonists, 5-HT1A receptor agonist, adverse events, drug tolerability
- MeSH terms
- Venlafaxine Hydrochloride, Vortioxetine, Adult, Cyclohexanols, Major Depressive Disorder, Double-Blind Method, Female, Humans, Male, Middle Aged, Piperazines, Placebos, Psychiatric Status Rating Scales, Sulfides, Treatment Outcome, Antidepressive Agents, Second-Generation, Diagnostic and Statistical Manual of Mental Disorders, Receptor, Serotonin, 5-HT1A
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