Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04806230 |
| Other study ID # |
PAPA123 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 1, 2011 |
| Est. completion date |
September 30, 2013 |
Study information
| Verified date |
March 2021 |
| Source |
Linkoeping University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
Description:
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.
