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Hormone Therapy

Hormone Therapy for Postpartum Depression

Phase 2
Recruiting
Led By Peter J Schmidt, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up ongoing

Summary

This trial is designed to study whether postpartum depression is caused by the sudden withdrawal of estrogen and progesterone.

Who is the study for?
This trial is for women aged 18-50 who have experienced major depression or mood disorders within three months after childbirth, are in good health, and have had a stable menstrual cycle for at least three months. They should not be pregnant or breastfeeding and must have been well for at least one year without any history of severe postpartum mental health issues.
What is being tested?
The study tests if hormone changes trigger postpartum depression by simulating pregnancy hormones with Estradiol and Progesterone, then suddenly stopping them. Some participants will continue the hormones longer to compare effects on mood and behavior.
What are the potential side effects?
Possible side effects may include mood swings, hormonal imbalance symptoms like hot flashes or vaginal dryness, injection site reactions from hormone treatments, and general discomfort associated with abrupt hormonal withdrawal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~ongoing
This trial's timeline: 3 weeks for screening, Varies for treatment, and ongoing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Outcome measures will include mood, behavioral, and hormonal parameters as well as response to o-CRH.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Group 2, Continued Replacement GroupActive Control2 Interventions
12 weeks of hormone addback
Group II: Group 1, Hormone and Placebo GroupPlacebo Group3 Interventions
8 weeks of hormonal addback plus 4 weeks of placebo

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,740,072 Total Patients Enrolled
19 Trials studying Postpartum Depression
7,620 Patients Enrolled for Postpartum Depression
Peter J Schmidt, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
13 Previous Clinical Trials
3,808 Total Patients Enrolled
2 Trials studying Postpartum Depression
80 Patients Enrolled for Postpartum Depression
Pedro E Martinez, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
2 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

Estradiol (Hormone Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT00001481 — Phase 2
Postpartum Depression Research Study Groups: Group 1, Hormone and Placebo Group, Group 2, Continued Replacement Group
Postpartum Depression Clinical Trial 2023: Estradiol Highlights & Side Effects. Trial Name: NCT00001481 — Phase 2
Estradiol (Hormone Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00001481 — Phase 2
~1 spots leftby May 2025
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