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Hormone Therapy

Pregnenolone for Depression (SADIE-P Trial)

N/A
Recruiting
Led By Hadine Joffe, MD MSc
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy women ages 40 to 60 years in the menopause transition
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 weeks

Summary

"This trial aims to investigate how a hormone called allopregnanolone, which is increased through pregnenolone supplementation, impacts behavior and brain function related to perimenopausal depression."

Who is the study for?
This trial is for women aged 40 to 60 who are going through menopause and experiencing depression. They can be on stable psychotropic medications, must understand basic math, and agree to participate by signing a consent form.
What is being tested?
The study is testing the effects of pregnenolone, a substance that may influence mood changes during menopause, compared with a placebo (a treatment with no active drug).
What are the potential side effects?
While specific side effects aren't listed here, pregnenolone could potentially cause hormonal imbalances, mood swings, headaches or other common medication-related side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a woman aged 40-60 going through menopause.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Within-person change in score on the Ruminative Responses Scale

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: pregnenoloneExperimental Treatment1 Intervention
Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks
Group II: placeboPlacebo Group1 Intervention
Participants will take placebo twice per day for four weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
pregnenolone
2007
Completed Phase 2
~130

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,669 Previous Clinical Trials
11,877,736 Total Patients Enrolled
29 Trials studying Depression
115,895 Patients Enrolled for Depression
Hadine Joffe, MD MScPrincipal InvestigatorBrigham and Women's Hospital
4 Previous Clinical Trials
135 Total Patients Enrolled
1 Trials studying Depression
32 Patients Enrolled for Depression
Katherine Burdick, PhDPrincipal InvestigatorBrigham and Women's Hospital
4 Previous Clinical Trials
182 Total Patients Enrolled
~53 spots leftby Jul 2027
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