Evidence map›Paper›PMID 31094901›Full record

Trial reportInternational clinical psychopharmacology2019

Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 2-week, randomized, double-blind, placebo-controlled study.

Eduard Vieta, Ioana Florea, Simon Nitschky Schmidt, Johan Areberg, Anders Ettrup

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in International clinical psychopharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02919501 (Interventional, Randomised, Double-blind, Parallel-group Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
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.

NCT02919501 phase2completednot on this map

Interventional, Randomised, Double-blind, Parallel-group Study of the Efficacy and Safety of Initial Administration of 17 mg Vortioxetine Intravenously With 10 mg/Day Vortioxetine Orally in Patients With Major Depressive Disorder

TypeinterventionalSponsorH. Lundbeck A/SRan2016 to 2017Enrolled55ConditionsDepressive Disorder, MajorArmsVortioxetine (IV), Placebo (IV), Vortioxetine (tablet)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. 5-HT Receptors and the Development of New Antidepressants.International journal of molecular sciences · 2021
    Review
  8. Review
  9. Article
  10. Review
  11. Review
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

5 authors.

Eduard VietaHospital Clinic, Institute of Neurosciences, University of Barcelona, IDIBAPS, CIBERSAM, Barcelona, Catalonia, Spain.
Ioana FloreaH. Lundbeck A/S, Valby, Denmark.
Simon Nitschky SchmidtH. Lundbeck A/S, Valby, Denmark.
Johan ArebergH. Lundbeck A/S, Valby, Denmark.
Anders EttrupH. Lundbeck A/S, Valby, Denmark.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This 2-week randomized, double-blind, placebo-controlled fixed-dose study (NCT02919501) explored the potential of accelerating onset of antidepressant efficacy and plasma exposure with single-dose intravenous vortioxetine at oral vortioxetine treatment initiation. Outpatients (ages 18-65 years) with major depressive disorder and a current depressive episode (Montgomery Åsberg Depression Rating Scale total score ≥30) were randomized to an initial single dose of either intravenous vortioxetine 17 mg (n = 27) or intravenous placebo (n = 28), both treatments followed by 2 weeks of oral vortioxetine (10 mg/day). From baseline to day 7, both groups exhibited fast and substantial improvements by approximately 14 Montgomery Åsberg Depression Rating Scale points, with no statistically significant treatment difference for this primary endpoint. Improvements were substantial already within 24 hours, with numerical treatment differences of 1.3 and 1.6 points at days 1 and 3, respectively, in favour of intravenous vortioxetine + oral vortioxetine. Pharmacokinetic data confirmed that intravenous vortioxetine facilitated reaching steady-state plasma concentration within 24 hours. Intravenous vortioxetine + oral vortioxetine was safe and well-tolerated, with nausea as the most common adverse event. This study supported intravenous vortioxetine as a means of rapidly reaching therapeutic vortioxetine blood levels.

Indexed as

AdolescentAdultAgedAntidepressive AgentsDouble-Blind MethodFemaleHumansMajor Depressive DisorderMaleMiddle AgedNauseaPsychiatric Status Rating ScalesSelective Serotonin Reuptake InhibitorsSerotonin 5-HT1 Receptor AgonistsSerotonin 5-HT3 Receptor AntagonistsTreatment OutcomeAntidepressive AgentsSelective Serotonin Reuptake InhibitorsSerotonin 5-HT1 Receptor AgonistsSerotonin 5-HT3 Receptor AntagonistsVortioxetine

Identifiers

PMID31094901
PMCPMC6587371

What OpenQuestion holds

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Registered trials

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.