Estradiol for Postpartum depression | Perinatal depression

Inclusion criteria

• {"criterion_text":"- Women between 18 and 45 years and pregnant in the third trimester."}
• {"criterion_text":"- 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

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

Primary endpoints

• {"endpoint_text":"- Clinical depression according to DSM-V criteria. Between 2 weeks and 6 months postpartum","definition_or_measurement_approach":"Clinical diagnosis according to DSM-V criteria between 2 weeks and 6 months postpartum."}

Denmark

Earliest CTIS Part Ii Submission Date

11-09-2024

Latest Decision Or Authorization Date

08-10-2024

Processing Time Days

27

Number Of Sites

4

Number Of Participants

220

Primary sponsor

Full Name

Rigshospitalet

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}