Maternal Mental Health Trial

NCT04685148 | Recruiting Phase 1 DMC

• 1 other identifier: 2020-001592-33
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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%.

Conditions

Major Depressive Disorder; Postpartum Depression

Keywords

Postpartum period; Mother-infant interaction; Personalised prevention; Perinatal depression; Hormone sensitivity; Estradiol

Outcome Measures

Primary Outcomes (1)

• Number of participants with Major Depression Disorder

  Clinical diagnosis assessed by DSM-V criteria

  0-6 months postpartum

Secondary Outcomes (28)

• EPDS Depressive symptoms

  8-10 weeks postpartum

• HamD6 Depressive symptoms

  8-10 weeks postpartum

• Maternal mental wellbeing

  8-10 weeks postpartum

• Maternal anxiety

  8-10 weeks postpartum

• Parental stress

  8-10 weeks postpartum

Study Arms (2)

Intervention

EXPERIMENTAL

Estradiol patches (200 μg per day) 0-3 weeks postpartum.

Drug: Transdermal patch estradiol

Placebo

PLACEBO COMPARATOR

Placebo patches (Coloplast Comfeel) for 0-3 weeks postpartum

Drug: Transdermal patch placebo

Interventions

Transdermal patch estradiol DRUG

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

Intervention

Transdermal patch placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Singleton pregnant
• Prior history of perinatal depression
• Age between 18 and 45 years

You may not qualify if:

• Moderate to severe depression with onset during pregnancy
• Severe psychiatric disorders (e.g. disorders with psychotic symptoms, schizophrenia, bipolar disorders, inpatient eating disorders and inpatient obsessive-compulsive disorders)
• Previous suicide attempts without having a depressive episode
• Prior history or ongoing neurological disorders (e.g. migraine or epilepsy)
• Severe somatic illness
• Prior history or ongoing cancer
• Prior history of venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or thrombophilia, or other risk factors clinically assessed after thrombophilia screening
• Deep vein thrombosis or pulmonary embolism in current pregnancy
• Pregnancy-induced hypertension or preeclampsia
• Pre-existing atherosclerosis or well-known cardiovascular risk factors (e.g. diabetes, hypertension)
• Other contraindication for oestrogen treatment (e.g. acute liver failure, severe varicose veins)
• Use of psychotropic pharmacology, except for short-term sleep support treatment
• Non-fluent in Danish or pronounced vision or hearing loss
• Body Mass Index (BMI) \>35 kg/m2
• Ongoing alcohol or drug abuse

Sponsors & Collaborators

• Vibe G Frøkjær, MD, PhD: lead
• Herlev Hospital: collaborator
• Hvidovre University Hospital: collaborator

Study Sites (1)

Neurobiology Researc hUnit

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (1)

• Hogh S, Hegaard HK, Renault KM, Cvetanovska E, Kjaerbye-Thygesen A, Juul A, Borgsted C, Bjertrup AJ, Miskowiak KW, Vaever MS, Stenbaek DS, Dam VH, Binder E, Ozenne B, Mehta D, Frokjaer VG. Short-term oestrogen as a strategy to prevent postpartum depression in high-risk women: protocol for the double-blind, randomised, placebo-controlled MAMA clinical trial. BMJ Open. 2021 Dec 30;11(12):e052922. doi: 10.1136/bmjopen-2021-052922.

  PMID: 35763351 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression, Postpartum

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Vibe Gedsø Frøkjær, MD, PhD

  Neurobiology Research Unit, copenhagen University hospital, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vibe Gedsø Frøkjær, MD, PhD

CONTACT

+45 35456714; vibe@nru.dk

Stinne Høgh, RM, MSc

CONTACT

+45 22973556; stinne.hoegh@regionh.dk

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 28, 2020
• Study Start: February 3, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: September 23, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We expected that data will come available December 2026 and be available for approx. 4 years.
• Access Criteria: Data will be available on reasonable request with approval by the Danish Data Protection Agency and with a signed agreement.

Locations

DK (1)