Maternal Mental Health Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Transdermal patch estradiol: Estradiol patches (200 μg per day by transdermal delivery) will be administered at day 0 (+1) to day 21 postpartum.

Transdermal patch placebo: Placebo patches will be administered at day 0 (+1) to day 21 postpartum.

Study summary

Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones, particularly estradiol, across pregnancy to postpartum. This trial aims 1) to evaluate the preventive effect of transdermal estradiol treatment in the immediate postpartum on depressive episodes in a subgroup of women at high-risk for perinatal depression, and 2) to determine if a set of biomarker gene transcripts can identify this subgroup and thus form the basis for future personalised prevention or treatment.

The MAMA Trial is a double-blind, 1:1 randomised, placebo-controlled trial. The trial involves maternity wards at three university hospitals in the Capital Region of Denmark. Women who are singleton pregnant in the third trimester with a prior history of perinatal depression are eligible to participate. Participants will be randomised to either estradiol patches (200 μg per day) or placebo patches for three weeks starting immediately postpartum.

The primary statistical analysis will be performed based on the intention-to-treat principle. A sample size of 220 will provide the trial with 80% power (alpha 0.05, beta 0.2) to detect a reduction in postpartum depression of 50% and to tolerate a drop-out of around 20%.

Eligibility

Primary outcome measure(s)

• Number of participants with Major Depression Disorder — 0-6 months postpartum
  Clinical diagnosis assessed by DSM-V criteria

Trial sites (1)

Other trials for the same condition