Maternal Mental Health (MAMA) Study. Short time treatment with female sex hormone to prevent postpartum depression in a high-risk group

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Pediatric, Healthy volunteers

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Psychiatry and Psychology [F] - Mental Disorders [F03]

Trial duration

8 Oct 2024 → ongoing

Decision date (initial)

2024-10-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Independent Research Fund Denmark · Rigshospitalets forskningspulje · Desiree Ydes Fond

External identifiers

EU CT number

2024-518028-63-00

EudraCT number

2020-001592-33

ClinicalTrials.gov

NCT04685148

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis

To evaluate if short-term estradiol administration relative to placebo in the immediate postpartum period (day 0 to day 21) prevents depressive episodes in women with a history of postpartum depression

Secondary objectives 5

1. To evaluate if short-term estradiol administration in the immediate postpartum affects the early mother-infant interaction and the proportion of women who exclusively breastfeed their infants.
2. To determine if candidate biomarkers (gene transcription and DNA methylation based) of estrogen sensitivity identify women who benefit from the short-term estradiol regimen.
3. If brain 5-HT1BR binding is associated with depressive symptoms about 8 weeks postpartum, possibly in a manner dependent on treatment status (active vs. placebo at week 0-3).
4. If brain reward activity is affected by breastfeeding.
5. If brain reward activity after breastfeeding is associated with brain 5-HT1BR binding. 6) If the brain GABA level is associated with anxiety symptoms about 8 weeks postpartum, possibly in a manner dependent on treatment status (active vs. placebo at week 0-3)

Conditions and MedDRA coding

Perinatal depression with postpartum onset

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. Women between 18 and 45 years and pregnant in the third trimester.
2. Previously perinatal depression with the onset of depressive episode in pregnancy or within 6 months of birth or untreated depressive episode assessed by retrospective interview by healthcare professional.

Exclusion criteria 20

1. Antidepressant treatment by inclusion in the study.
2. Moderate to severe depression developed in pregnancy before day 0 postpartum.
3. Severe mental illness, e.g. diseases of the schizophrenic spectrum, psychotic conditions, inpatient active eating disorder or hospitalising OCD, and bipolar affective disorder.
4. Previous suicide attempts outside the depressive episode.
5. Present or previous neurological disease including migraines and epilepsy.
6. Severe medical disease.
7. Past or ongoing cancer.
8. Previous venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or known thrombophilic diseases and risk factors clinically assessed after thrombophilic screening.
9. Deep vein thrombosis or pulmonary embolism in current pregnancy.
10. Pregnancy-related hypertension or preeclampsia.
11. Manifest atherosclerosis or known cardiovascular risk factors (including diabetes, hypertension).
12. Other contraindication for estrogen treatment (e.g. acute liver disease, varicicated varicencies).
13. Use of psychotropic pharmacology, except for short-term sleep support treatment, which is likely to influence the results of the study.
14. Non-fluent in Danish or pronounced vision or hearing loss.
15. Current or previous learning difficulties.
16. BMI >35 kg/m2.
17. Current alcohol or drug abuse.
18. Multiple pregnancy.
19. Severe postpartum haemorrhage (>1500 ml).
20. Serious illness or neonatal death in the child.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Clinical depression according to DSM-V criteria. Between 2 weeks and 6 months postpartum

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Blegdamsvej 9

City

Copenhagen Oe

Postcode

2100

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Vibe Gedsoe Froekjaer

Public contact point

Organisation

Rigshospitalet

Contact name

Vibe Gedsoe Froekjaer

Third parties 1

Locations

1 EU/EEA country · 4 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications