Background
Women are at increased risk for depression in life phases, where endogenous sex steroid hormone milieu changes; such as during late pregnancy to postpartum. This includes a subtype of Major Depressive Disorder, perinatal depression (PND), that affects 10-15% of mothers postpartum and has a recurrence rate of 40%. Women who develop PND might be particularly sensitive to the rapid and large changes in sex steroid hormone milieu, seen in the transition from high levels of sex steroid hormones, in particular estradiol, in pregnancy to low levels in the hormone withdrawal phase postpartum. Thus, PND is most likely to have distinct pathophysiology, which may provide a unique opportunity for protecting mental health by targeted short-term prevention in the immediate postpartum period. Our hypothesis is that changes in the sex hormone environment in particularly hormone-sensitive women can trigger depressive episodes and that we through the administration of hormone (patch) given in the immediate postpartum period can prevent these mechanisms and thus prevent postpartum depression.
Aim
The aim of this trial is 1) to evaluate the preventive effect of transdermal estradiol treatment in the immediate postpartum on depressive episodes in a subgroup of women who are expected to be particularly sensitive to estradiol fluctuations, and 2) to determine if a set of biomarker gene transcripts can identify this subgroup and thus form the basis for future personalized prevention or treatment.
Study design
The Maternal Mental Health (MAMA) Trial is designed as a double-blind, 1:1 randomized, placebo-controlled multi-center trial. Participants will be randomised to either estradiol patches (200 μg per day by transdermal delivery) or placebo patches for three weeks, which will be administered at day 0 (+1) postpartum at a visit by a research assistant and twice weekly self-administered by the trial participants in a double-blind fashion.
Participating in the MAMA Trial includes four visits of approximately one hour each. In addition, the participants are asked to answer online questionnaires four times during the study period. All participants will be followed-up at 1 week postpartum, three weeks postpartum, 8-10 weeks postpartum, and six months postpartum.
The participants’ mental state will be rated using face-to-face semi-structured interviews (Hamilton Depression Rating Scale 6 items, HAMD-6) by a trained healthcare professional. Self-reported psychometrics will be collected through established online procedures and implemented questionnaires. The study program furthermore consists of neuropsychological testing, saliva samples, hair samples, blood samples for determining relevant blood biomarkers including sex steroid hormones and buccal swabs from the infant.
220 women and their 220 infants are expected to participate in the MAMA trial.
Contact:
Project responsible medical doctor Vibe Gedsø Frøkjær and midwife Stinne Høgh
Telephone: 24429189
E-mail: 
@mama_trial