Evidence map›Paper›PMID 11554425›Full record

Trial reportEuropean journal of drug metabolism and pharmacokinetics

Drug-drug interaction studies with mirtazapine and carbamazepine in healthy male subjects.

J Sitsen, F Maris, C Timmer

Abstract readClinical TrialRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of drug metabolism and pharmacokinetics. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.7field-weighted citation impact, top 32% 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

3 citing papers in PubMed, 28 citations in OpenAlex.

  1. Article
  2. Review
  3. 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

3 authors at 1 institution in 1 country.

J SitsenN. V. Organon Oss, The Netherlands.
F Maris
C Timmer
SNV Netherlands Development Organisation · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

In two studies, the effects of the potentially interacting drugs mirtazapine and carbamazepine on their pharmacokinetics have been investigated. Subjects were treated with carbamazepine combined with placebo for 21 days and subsequently with carbamazepine combined with mirtazapine for another 7 days (Study A) or with mirtazapine combined with placebo for 7 days and subsequently mirtazapine combined with carbamazepine for another 21 days (Study B). Pharmacokinetic results indicate that carbamazepine decreased significantly AUC and Cmax values for mirtazapine and increased values for demethyl-mirtazapine Cmax. Mirtazapine had no effect on carbamazepine pharmacokinetic parameters, but did lower carbamazepine-10,11-epoxide levels. Mirtazapine did not affect the single dose kinetics or the enzyme inducing properties of carbamazepine. VAMRS alertness scores reflected the somnolence-inducing effects of carbamazepine and mirtazapine and psychometric test results revealed impairment of specific tasks. The combination was safe and routine laboratory testing did not reveal clinically relevant abnormalities. The dose of mirtazapine in patients on carbamazepine may have to be increased for optimal antidepressant efficacy.

Indexed as

AdolescentAdultAnticonvulsantsAntidepressive Agents, Second-GenerationArea Under CurveBiotransformationCarbamazepineDrug InteractionsEnzyme InductionHumansMaleMianserinMiddle AgedMirtazapinePsychometricsPsychomotor PerformanceAnticonvulsantsAntidepressive Agents, Second-GenerationCarbamazepineMianserinMirtazapine

Identifiers

PMID11554425
OpenAlexW1985155015

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.