Evidence map›Paper›PMID 29098341›Full record

Trial reportPsychopharmacology2018

Acute administration of roflumilast enhances sensory gating in healthy young humans in a randomized trial.

Pim R A Heckman, Marlies A Van Duinen, Arjan Blokland, Tolga Uz, Jos Prickaerts, Anke Sambeth

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Psychopharmacology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01433666 (Effects of Roflumilast on Cognition in Healthy Adults), 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
0.8field-weighted citation impact, top 28% 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.

NCT01433666 phase2completednot on this map

Effects of Roflumilast on Cognition in Healthy Adults: a Behaviour-EEG Study

TypeinterventionalSponsorMaastricht University Medical CenterRan2011 to 2013Enrolled22ConditionsDementiaArmsroflumilast (EU: Daxas, USA: Daliresp), Placebo, roflumilast
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Review
  5. 3D-QSAR Studies on High-affinity Phosphodiestera.Current medicinal chemistry · 2025
    Article
  6. Opportunities for use of neuroimaging in de-risking drug development and improving clinical outcomes in psychiatry: an industry perspective.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2024
    Review
  7. Article
  8. Drug Discovery and Development Targeting Dementia.Pharmaceuticals (Basel, Switzerland) · 2023
    Review
  9. Clinical Implication of Phosphodiesterase-4-Inhibition.International journal of molecular sciences · 2022
    Review
  10. Article
  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

6 authors at 2 institutions in 2 countries.

Pim R A HeckmanDepartment of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, 6200 MD, Maastricht, The Netherlands.
Marlies A Van DuinenDepartment of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, 6200 MD, Maastricht, The Netherlands.
Arjan BloklandDepartment of Neuropsychology and Psychopharmacology, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands.
Tolga UzExperimental Medicine CNS, Takeda Development Center Americas, Inc., Deerfield, MA, USA.
Jos PrickaertsDepartment of Psychiatry and Neuropsychology, School for Mental Health and Neuroscience, Maastricht University, 6200 MD, Maastricht, The Netherlands.
Anke SambethDepartment of Neuropsychology and Psychopharmacology, Maastricht University, PO Box 616, 6200 MD, Maastricht, The Netherlands. anke.sambeth@maastrichtuniversity.nl.
Maastricht University · NLTakeda (United States) · US

Funding

The Netherlands Organization for Health Research and Development 95110091
6 · The paper itself

Abstract

introductionSensory gating is a process involved in early information processing which prevents overstimulation of higher cortical areas by filtering sensory information. Research has shown that the process of sensory gating is disrupted in patients suffering from clinical disorders including attention deficit hyper activity disorder, schizophrenia, and Alzheimer's disease. Phosphodiesterase (PDE) inhibitors have received an increased interest as a tool to improve cognitive performance in both animals and man, including sensory gating.

methodsThe current study investigated the effects of the PDE4 inhibitor roflumilast in a sensory gating paradigm in 20 healthy young human volunteers (age range 18-30 years). We applied a placebo-controlled randomized cross-over design and tested three doses (100, 300, 1000 μg).

resultsResults show that roflumilast improves sensory gating in healthy young human volunteers only at the 100-μg dose. The effective dose of 100 μg is five times lower than the clinically approved dose for the treatment of acute exacerbations in chronic obstructive pulmonary disease (COPD). No side-effects, such as nausea and emesis, were observed at this dose. This means roflumilast shows a beneficial effect on gating at a dose that had no adverse effects reported following single-dose administration in the present study.

conclusionThe PDE4 inhibitor roflumilast has a favorable side-effect profile at a cognitively effective dose and could be considered as a treatment in disorders affected by disrupted sensory gating.

Indexed as

AdolescentAdultAminopyridinesAnimalsBenzamidesCyclopropanesDose-Response Relationship, DrugDouble-Blind MethodElectroencephalographyEvoked Potentials, AuditoryFemaleHumansMaleNauseaPhosphodiesterase 4 InhibitorsSensory GatingAminopyridinesBenzamidesCyclopropanesPhosphodiesterase 4 InhibitorsRoflumilastClinical trialPhosphodiesterasePhosphodiesterase inhibitorRoflumilastSensory gating

Identifiers

PMID29098341
PMCPMC5748397
OpenAlexW2766548708

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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.