Evidence map›Paper›PMID 21801198›Full record

ArticleBritish journal of clinical pharmacology2012

Clomipramine concentration and withdrawal symptoms in 10 neonates.

Peter G J ter Horst, Susanne van der Linde, Jan Pieter Smit, Jan den Boon, Richard A van Lingen, Frank G A Jansman, Lolkje T W De Jong-van den Berg, Bob Wilffert

Open access · bronzeAbstract read
In one paragraph

Article in British journal of clinical pharmacology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
2.5field-weighted citation impact, top 11% 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

9 citing papers in PubMed, 29 citations in OpenAlex.

  1. Article
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  7. Article
  8. Pharmacokinetics of clomipramine during pregnancy.European journal of clinical pharmacology · 2015
    Article
  9. 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

8 authors at 4 institutions in 2 countries.

Peter G J ter HorstUnit of Pharmacoepidemiology and Pharmacoeconomics, Department of Pharmacy, University of Groningen, Groningen, The Netherlands. p.g.j.ter.horst@isala.nl
Susanne van der Linde
Jan Pieter Smit
Jan den Boon
Richard A van Lingen
Frank G A Jansman
Lolkje T W De Jong-van den Berg
Bob Wilffert
University of Groningen · NLAmalia Kinderziekenhuis · NLAustralia New Zealand Gynaecological Oncology Group · AUDeventer Ziekenhuis · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimAfter in utero exposure to tricyclic antidepressants, neonatal withdrawal symptoms have been reported with an estimated incidence between 20 and 50%; however, few data are available for clomipramine. This could also be the case for neonatal pharmacokinetic clomipramine parameters and so this study was set up.

methodsBabies exposed to clomipramine in utero were included in an observational study, approved by the local ethics committee, after written informed consent. Withdrawal symptoms were scored at 12, 24 and 48 h after birth using the Finnegan score. Plasma concentrations were determined using an in-house-developed, validated liquid chromatography with mass detection (LC-MSMS) method at 0, 12, 24 and 48 h after birth.

resultsWe found that three of 11 pregnancies were complicated with pre-eclampsia. Ten neonates were observed for clomipramine withdrawal symptoms. The observed withdrawal symptoms were too short a period of sleep after feeding (6), poor feeding (3), mild to severe tremors (6), hyperactive Moro reflex (3) and respiratory rate >60 breaths min(-1). Serious withdrawal reactions, such as tachycardia and cyanosis, were seen. We calculated a half-life value of 42 ± 16 h for clomipramine in neonates. Only a weak correlation was found between withdrawal reactions and clomipramine plasma concentration or desmethylclomipramine plasma concentration.

conclusionsIn neonates, clomipramine is eliminated with a half-life value of 42 h, compared with 20 h in adults. In two of 10 neonates, tachycardia and cyanosis were seen as serious withdrawal symptoms after maternal use of clomipramine.

Indexed as

Maternal-Fetal ExchangeAdultAntidepressive Agents, TricyclicClomipramineDepressive DisorderFemaleHalf-LifeHumansInfant, NewbornMaleNetherlandsPregnancyPregnancy ComplicationsSubstance Withdrawal SyndromeAntidepressive Agents, TricyclicClomipramine

Identifiers

PMID21801198
PMCPMC3269588
OpenAlexW2167189410

What OpenQuestion holds

Textmetadata
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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.