NCT06238700 · Beth Israel Deaconess Medical Center
Study on Allopregnanolone and Depression in Women Across the Menopause Transition
(SADIE-P)
What this study is about
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
View original scientific description
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations