Evidence map›Paper›PMID 23975654›Full record

Trial reportClinical drug investigation2013

Pharmacokinetic drug interactions involving vortioxetine (Lu AA21004), a multimodal antidepressant.

Grace Chen, Ronald Lee, Astrid-Maria Højer, Jeppe Klint Buchbjerg, Michael Serenko, Zhen Zhao

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical drug investigation, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 7 pooled it
9.9field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 7 syntheses or guidelines pooled it, 100 citations in OpenAlex.

  1. Pooled it
  2. Use of vortioxetine in different neurological fields: a systematic review and future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Grace ChenClinical Pharmacology, Takeda Development Center Americas, One Takeda Parkway, Deerfield, IL, 60015, USA, grace.chen@takeda.com.
Ronald Lee
Astrid-Maria Højer
Jeppe Klint Buchbjerg
Michael Serenko
Zhen Zhao
Lundbeck (Denmark) · DKTakeda (Japan) · JPTakeda (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectiveThe identification and quantification of potential drug-drug interactions is important for avoiding or minimizing the interaction-induced adverse events associated with specific drug combinations. Clinical studies in healthy subjects were performed to evaluate potential pharmacokinetic interactions between vortioxetine (Lu AA21004) and co-administered agents, including fluconazole (cytochrome P450 [CYP] 2C9, CYP2C19 and CYP3A inhibitor), ketoconazole (CYP3A and P-glycoprotein inhibitor), rifampicin (CYP inducer), bupropion (CYP2D6 inhibitor and CYP2B6 substrate), ethinyl estradiol/levonorgestrel (CYP3A substrates) and omeprazole (CYP2C19 substrate and inhibitor).

methodsThe ratio of central values of the test treatment to the reference treatment for relevant parameters (e.g., area under the plasma concentration-time curve [AUC] and maximum plasma concentration [C max]) was used to assess pharmacokinetic interactions.

resultsCo-administration of vortioxetine had no effect on the AUC or C max of ethinyl estradiol/levonorgestrel or 5'-hydroxyomeprazole, or the AUC of bupropion; the 90 % confidence intervals for these ratios of central values were within 80-125 %. Steady-state AUC and C max of vortioxetine increased when co-administered with bupropion (128 and 114 %, respectively), fluconazole (46 and 15 %, respectively) and ketoconazole (30 and 26 %, respectively), and decreased by 72 and 51 %, respectively, when vortioxetine was co-administered with rifampicin. Concomitant therapy was generally well tolerated; most adverse events were mild or moderate in intensity.

conclusionDosage adjustment may be required when vortioxetine is co-administered with bupropion or rifampicin.

Indexed as

AdolescentAdultAntidepressive AgentsAntifungal AgentsBupropionCohort StudiesContraceptives, Oral, HormonalCross-Over StudiesDrug InteractionsEnzyme InductionEnzyme InhibitorsFemaleFluconazoleHumansKetoconazoleMaleAntidepressive AgentsAntifungal AgentsBupropionContraceptives, Oral, HormonalEnzyme InhibitorsFluconazoleKetoconazoleOmeprazolePiperazinesRifampinSulfidesVortioxetine

Identifiers

PMID23975654
PMCPMC3775155
OpenAlexW2055651890

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.