Review the details below, then apply to join this clinical trial.
At a Glance
Age
40 – 60
Sex
Female
Study type
Interventional
Purpose
Other
Participants needed
80 (estimated)
Sponsor
Beth Israel Deaconess Medical Center · Other
Who this trial is looking for
This trial is looking for healthy women aged 40 to 60 who have depressive symptoms during menopause. Participants will help researchers understand how a treatment might affect mood and brain function.
Are You a Good Fit for This Trial?
Must not be takingSystemic corticosteroid
Rules you outActive substance use disordersUnstable medical conditions
You may be able to join if
I am a healthy woman aged 40 to 60.
I have depressive symptoms.
I can read Arabic numerals and do simple math.
I can provide written consent.
You may not be able to join if
I am taking systemic hormone therapy.
I have a current suicidal plan or idea.
I have a substance use disorder.
I have unstable medical conditions.
I have obstructive sleep apnea or other sleep disorders.
I have a known allergy to progesterone, allopregnanolone, or pregnenolone.
I have a history of serious head injury.
I cannot comply with barrier contraceptive methods.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Healthy women ages 40 to 60 years in the menopause transition
* Depressive symptoms
* Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
* Able to read Arabic numerals and perform simple arithmetic
* Able to provide written i…
Inclusion Criteria:
* Healthy women ages 40 to 60 years in the menopause transition
* Depressive symptoms
* Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
* Able to read Arabic numerals and perform simple arithmetic
* Able to provide written informed consent
Exclusion Criteria:
* Systemic hormone therapy
* Contraindicated medications with pregnenolone
* Systemic corticosteroid
* Other psychiatric illnesses that are considered to be primary
* Current suicidal ideation
* Active substance use disorders
* Unstable medical conditions
* Obstructive sleep apnea or other primary sleep disorders
* Abnormal hepatic and renal function
* Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone
* History of head injury resulting in loss of consciousness \> 20 min
* Inability to comply with barrier contraceptive methods
* Known intellectual disability
* Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition
* Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data
* Inability to comply with study procedures
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