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Completed

NCT Number: NCT04806230

Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study

The study was a prospective naturalistic PK study of five frequently used antidepressant drugs in pregnant women; citalopram (CIT), escitalopram (ECIT), sertraline (SERT), mirtazapine (MIRT) and venlafaxine VEN) and their major metabolites (Table 1). After signing informed consent pregnant women with ongoing antidepressant treatment, regardless of indication, were recruited at nine antenatal care centers in mid- and small cities and villages in the Southeast Sweden between April 2011 and September 2013.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Linköping University

Linköping, Sweden

About this study

Serum samples for the antidepressant drug and metabolite(s) concentrations, albumin and creatinine were collected at the first prenatal appointment and at gestational week 15, 20, 25, 35 and at partus. The time interval between drug intake and sampling was registered in all cases. At partus, a serum samples from the umbilical cord was collected drug concentration was assessed. At the first prenatal appointment a blood sample for analyzing the CYP2D6 and CYP2C19 genotype was also collected. All drug concentration analysis were executed post hoc, after last partus, whereas physiological parameters were part of normal routine sampling. Concomitant medication, weight changes and smoking habits were registered throughout the pregnancies.

Our main findings were that dose corrected serum concentrations of neither sertralin nor citalopram changed during the pregnancy. In addition, concentrations of escitalopram and venlafaxine and their metabolites appeared to be stable throughout pregnancy, even though a linear mixed models statistic calculation could not be done due small number of samples.

Results from previous research on sertraline PK during pregnancy are inconclusive. Two studies suggested decreased levels (Freeman, Sit 2), while one study indicated increased levels (Westin). Previous studies, except for Westin's are, however, limited by small sample sizes (six and eight) and a substantial inter-individual variance.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pregnancy
  • Ongoing treatment with one of the five studied antidepressants.

Exclusion criteria

  • None

Treatment and study plan

sertraline, mirtazapine, venlafaxine, citalopram, escitalopram

Drug

Naturalistic treatment

Primary outcomes

  1. Serum concentrations of drugs and metabolites

    Time frame: 9 months

    levels of parent compound and metabolites in serum

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Registry information

Acronym: PAPA

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2021
Registry last updated
Mar 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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