This study targets women with moderate depression during pregnancy. We aim to investigate the direct effect of the newborn child and the long term consequences on the cognitive developement on children who´s mother has been treated with CBT alone or in combination with antidepressants.
The primary objective is to study the direct neonatal effects and the long-term consequences on cognitive development in children prenatal exposed to maternal sertraline treatment compared to exposure to maternal depression treated with only ICBT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
17
Karolinska University Hospital
Stockholm, Sweden
Cognitive development
The differences in cognitive development at 2 years evaluated by the standard Bayley Scales of Infant and Toddler Development third edition (BSID-III)®.
Time frame: 2 years
measure in MADRS_S
a) Add-on effect of sertraline measured in difference i) in self-report of depressive symptoms (MADRS-S),ii) in rate of remission from depression (measured by diagnostic psychiatric interview with MADRS at -12weeks, 14 weeks, and 30 weeks (= 3 months postpartum) of treatment
Time frame: 12 weeks, 14 weeks and 30 weeks
Stresshormone level
Effects on levels of S-hCG, cytokines,
Time frame: up to 3 months postpartum
Pharmacological assessment
Plasma sertraline concentrations.
Time frame: 4, 14, 18 weeks
Pharmacological assessment
Pharmacokinetic variations in the metabolism of sertraline. Assess activity of enzymes regulating the metabolism of sertralin.
Time frame: 4, 14, 18 weeks
Pharmacological assessment
Genetic variations in the metabolism of sertraline. Assess concentration of sertralin and markers for metabolism of sertralin on specific regions of sertralin pathways.
Time frame: 4, 14, 18 weeks
Pharmacological assessment
Effects on prolactin levels. Assess prolactin.
Time frame: 4, 14, 18 weeks
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