Evidence map›Paper›PMID 33751155›Full record

Trial reportEuropean journal of clinical pharmacology2021

Sertraline concentrations in pregnant women are steady and the drug transfer to their infants is low.

E Heinonen, M Blennow, M Blomdahl-Wetterholm, M Hovstadius, J Nasiell, A Pohanka, L L Gustafsson, K Wide

2 registry-linked trialsOpen access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European journal of clinical pharmacology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
4.7field-weighted citation impact, top 5% 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.

NCT02185547 phase4terminatednot on this map

Effects and Consequences for Mother and Child From Treatment for Depression, A Prospective Randomized, Placebo- Controlled, Trial With Internet-based Cognitive Behavior Therapy and Sertraline or Placebo for Moderate Depression in Pregnancy

TypeinterventionalSponsorKatarina WideRan2016 to 2019Enrolled17ConditionsPregnancy, Moderate DepressionArmsZoloft, ICBT
NCT06001021 nacompletednot on this mapstarted 2023, after this paper: background citation

The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioral Couple Therapy and Their Combination in Perinatal Distressed Couples: A Randomized Clinical Trial

TypeinterventionalSponsorSameera ShafiqRan2023 to 2023Enrolled96ConditionsPerinatal Depression, Perinatal AnxietyArmsPsychopharmacological Intervention, Cognitive Behavioral Couple Therapy, Combination of Psychopharmacological Intervention and CBCT, Placebo and No Intervention
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Pooled it
  2. Observational
  3. Prenatal serotonin reuptake inhibitor exposure and maternal depression symptoms are associated with altered fetal brain and placental development.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026
    Observational
  4. Article
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  6. Observational
  7. Article
  8. Article
  9. Article
  10. Review
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  15. Review
  16. Sertraline-induced 5-HT dysregulation in mouse cardiomyocytes and the impact on calcium handling.American journal of physiology. Heart and circulatory physiology · 2024
    Article
  17. Review
  18. Article
  19. Article
  20. Pharmacokinetics of Antidepressants in Pregnancy.Journal of clinical pharmacology · 2023
    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 1 country.

E HeinonenDivision of Paediatrics at the Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden. essi.heinonen@ki.se.ORCID http://orcid.org/0000-0003-2107-0561
M BlennowDivision of Paediatrics at the Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.
M Blomdahl-WetterholmPsychiatry South West, Stockholm Healthcare Region, Stockholm, Sweden.
M HovstadiusDivision of Paediatrics at the Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.
J NasiellDepartment of Clinical Sciences, Danderyd Hospital, Karolinska Institute, Stockholm, Sweden.
A PohankaDivision of Clinical Pharmacology at the Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.
L L GustafssonDivision of Clinical Pharmacology at the Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.
K WideDivision of Paediatrics at the Department of Clinical Science, Intervention and Technology (CLINTEC), Karolinska Institute, Stockholm, Sweden.
Karolinska University Hospital · SEDanderyds sjukhus · SEHealthcare in Sweden · SEKarolinska Institutet · SE

Funding

Stockholms Läns Landsting 533069Stockholms Läns Landsting 571301Vetenskapsrådet 521-2012-3466
6 · The paper itself

Abstract

purposeSertraline, a selective serotonin reuptake inhibitor (SSRI), is one of the most commonly used antidepressant during pregnancy. Plasma sertraline concentrations vary markedly between individuals, partly explained by variability in hepatic drug metabolizing cytochrome P450-enzyme activity. Our purpose was to study the variability in the plasma concentrations in pregnant women and the passage to their infants.

methodPregnant women with moderate untreated depression were recruited in 2016-2019 in Stockholm Region and randomized to treatment with sertraline or placebo. All received Internet-based cognitive behavior therapy as non-medical treatment. Sertraline plasma concentrations were measured around pregnancy weeks 21 and 30, at delivery, 1-month postpartum, in cord blood and at 48 h of age in the infant. The clinical course of the infants was followed.

resultsNine mothers and 7 infants were included in the analysis. Median dose-adjusted sertraline concentration in second trimester was 0.15(ng/mL) /(mg/day), in third trimester and at delivery 0.19 and 1-month postpartum 0.25, with a 67% relative difference between second trimester and postpartum. The interindividual variation was 10-fold. Median concentrations in the infants were 33% and 25% of their mothers', measured in cord blood, and infant plasma, respectively. Only mild and transient adverse effects were seen on the infants.

conclusionPlacental passage of sertraline to the infant is low. However, the interindividual variation in maternal concentrations during pregnancy is huge, why therapeutic drug monitoring might assist in finding the poor metabolizers at risk for adversity and increase the safety of the treatment.

trial registrationThe trial was registered at clinicaltrials.gov July 9, 2014 with TRN: NCT02185547.

Indexed as

AdultAntidepressive AgentsCognitive Behavioral TherapyDepressive DisorderDouble-Blind MethodFemaleFetal BloodHumansInfant, NewbornMaleMilk, HumanPlacentaPostpartum PeriodPregnancyPregnancy TrimestersPrenatal Exposure Delayed EffectsAntidepressive AgentsSertralineAntenatal depressionInfantPharmacokineticsPregnancySelective serotonin reuptake inhibitorsTherapeutic drug monitoring

Identifiers

PMID33751155
PMCPMC8346399
OpenAlexW3138371212

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.