MAGDALENA: study protocol of a randomised, placebo-controlled trial on cognitive development at 2 years of age in children exposed to SSRI in utero

IntroductionTen per cent of all pregnant women are depressed. Standard therapy of pregnant women with moderate depression is selective serotonin reuptakeinhibitors (SSRI). Observational studies on neurodevelopment after fetal SSRI exposure show conflicting results. Our primary objective is to compar...

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Published in:	BMJ open Vol. 8; no. 8; p. e023281
Main Authors:	Heinonen, Essi, Szymanska-von Schultz, Barbara, Kaldo, Viktor, Nasiell, Josefine, Andersson, Ewa, Bergmark, Mikaela, Blomdahl-Wetterholm, Margareta, Forsberg, Lisa, Forsell, Erik, Forsgren, Anna, Frööjd, Sandra, Goldman, Amy, Nordenadler, Eva-Mari, Sklivanioti, Myrto, Blennow, Mats, Wide, Katarina, Gustafsson, Lars L
Format:	Journal Article
Language:	English
Published:	England BMJ Publishing Group LTD 01-08-2018 BMJ Publishing Group
Subjects:	Adaptation Age antenatal depression Antidepressants Autism Behavior modification Chemotherapy Cognitive development drug metabolism Evidence-based medicine Hypotheses Internet internet-based cognitive behaviour therapy Medicin och hälsovetenskap Mental depression Mental Health neurodevelopment Newborn babies Objectives Postpartum depression Preeclampsia Pregnancy Psychiatry Psychology Psychotherapy Psykologi Serotonin serotonin reuptake inhibitors Womens health Sweden serotonin reuptake inhibitors internet-based cognitive behaviour therapy antenatal depression neurodevelopment drug metabolism pregnancy
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Summary:	IntroductionTen per cent of all pregnant women are depressed. Standard therapy of pregnant women with moderate depression is selective serotonin reuptakeinhibitors (SSRI). Observational studies on neurodevelopment after fetal SSRI exposure show conflicting results. Our primary objective is to compare the cognitive development in children exposed to sertraline and maternal depression with those exposed to maternal depression and placebo in utero. We hypothesise that there is a significant neurodevelopmental difference between the groups. As a secondary objective, we study the add-on effect of sertraline to internet-based cognitive behavioural therapy (ICBT) to treat moderate depression during pregnancy.Methods and analysisMAGDALENA is a randomised, placebo-controlled, double-blinded trial in Stockholm Healthcare Region with 2.3 million inhabitants. The women are recruited in weeks 9–21 of pregnancy either through Antenatal Health Clinics or through social media. They are to be diagnosed with moderate depression without ongoing antidepressive therapy or any serious comorbidity. The women in the intervention arm receive sertraline combined with a 12-week period of ICBT; the control arm is treated with placebo and ICBT. We assess the cognitive development in the offspring at the age of 2 years using Bayley Scales of Infant and Toddler Development, third edition (BSID-III). We aim at recruiting 200 women, 100 women in each treatment arm, to ensure statistical power to detect a clinically relevant difference between the groups.Ethics and disseminationThis randomised trial will provide long-sought evidence about the effects of SSRI and maternal depression during pregnancy on the neurodevelopment in the offspring. The study is approved by the Regional Ethical Review Board at Karolinska Institutet in Stockholm and the Swedish Medical Products Agency. It is registered with the European Clinical Trials Database (EudraCT), Number: 2013-004444-31. Results will be disseminated at scientific conferences, published in peer-reviewed journals and made available to the public.Trial registration numberEudraCT2013-004444-31; Pre-results.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2018-023281