Maternal Mental Health (MAMA) Study. Short time estrogen as a candidate strategy to prevent postpartum depression in a high-risk group

Rigshospitalet4 个研究点分布在 1 个国家目标入组 220 人2024年10月8日

概览

阶段: 2 期
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: Rigshospitalet
入组人数: 220
试验地点: 4
主要终点: Clinical depression according to DSM-V criteria. Between 2 weeks and 6 months postpartum
状态: 尚未招募
最后更新: 去年

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

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

注册库

euclinicaltrials.eu

开始日期

2024年10月8日

结束日期

待定

最后更新

去年

研究类型

Interventional clinical trial of medicinal product

研究者

发起方

Rigshospitalet

责任方

Principal Investigator

主要研究者

Vibe Gedsoe Froekjaer

Scientific

Rigshospitalet

入排标准

入选标准

•Women between 18 and 45 years and pregnant in the third trimester.
•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.

排除标准

•Antidepressant treatment by inclusion in the study.
•Pregnancy-related hypertension or preeclampsia.
•Manifest atherosclerosis or known cardiovascular risk factors (including diabetes, hypertension).
•Other contraindication for estrogen treatment (e.g. acute liver disease, varicicated varicencies).
•Use of psychotropic pharmacology, except for short-term sleep support treatment, which is likely to influence the results of the study.
•Non-fluent in Danish or pronounced vision or hearing loss.
•Current or previous learning difficulties.
•BMI >35 kg/m
•Current alcohol or drug abuse.
•Multiple pregnancy.