2024-518028-63-00招募中2 期
Maternal Mental Health (MAMA) Study. Short time estrogen as a candidate strategy to prevent postpartum depression in a high-risk group
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 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
研究概览
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
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（0-17 Years, 18-64 Years）
- 接受健康志愿者
- 是
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.
- •Severe postpartum haemorrhage (>1500 ml).
- •Moderate to severe depression developed in pregnancy before day 0 postpartum.
- •Serious illness or neonatal death in the child.
- •Severe mental illness, e.g. diseases of the schizophrenic spectrum, psychotic conditions, inpatient active eating disorder or hospitalising OCD, and bipolar affective disorder.
- •Previous suicide attempts outside the depressive episode.
- •Present or previous neurological disease including migraines and epilepsy.
- •Severe medical disease.
- •Past or ongoing cancer.
- •Previous venous thromboembolism, myocardial infarction, cerebrovascular thromboembolism or known thrombophilic diseases and risk factors clinically assessed after thrombophilic screening.
- •Deep vein thrombosis or pulmonary embolism in current pregnancy.
结局指标
主要结局
Clinical depression according to DSM-V criteria. Between 2 weeks and 6 months postpartum
Clinical depression according to DSM-V criteria. Between 2 weeks and 6 months postpartum
次要结局
未报告次要终点
研究者
Vibe Gedsoe Froekjaer
Scientific
Rigshospitalet
研究点 (4)
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