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Official title Study on Allopregnanolone and Depression in Women Across the Menopause Transition
ClinicalTrials.gov ID: NCT06238700
What this study is testing
- What it's testing
- This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60, women only
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.