Study on Allopregnanolone and Depression in Women Across the Menopause Transition
Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 40 Years to 60 Years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how pregnenolone, which boosts the activity of a hormone called allopregnanolone, affects mood, behavior, and the brain. It is for women ages 40 to 60 with symptoms of depression during the years leading up to menopause.
This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Women ages 40 to 60 who are otherwise healthy and going through the change toward menopause.
- Have symptoms of depression.
- Mental health medicines are allowed if the dose stays the same before screening and during the study.
- Can read numbers and do simple math.
- Can give written consent to join the study.
Who can't join
- Use hormone therapy or corticosteroid medicines that affect the whole body, or medicines that cannot be taken with pregnenolone.
- Have another mental illness that is the main concern, current thoughts of suicide, or an active problem with alcohol or drug use.
- Have an unstable medical condition, abnormal liver or kidney function, or a health condition that the study doctor thinks makes joining too risky.
- Have sleep apnea, which causes breathing to stop and start during sleep, or another main sleep disorder.
- Have a known allergy to progesterone, allopregnanolone given as a medicine, or pregnenolone.
- Have a known intellectual disability or had a head injury that caused passing out for more than 20 minutes.
- Cannot follow the study steps or use barrier birth control, such as condoms.
- Are in, or recently were in, another clinical trial that could affect this study's risks or how its results are understood.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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
Study sites (1)
MA
- Beth Israel Deaconess Medical Center · Boston, MA 02215Aleta Wiley · Study contactMore trials in Boston