Recruiting

Allopregnanolone

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06238700

Conditions

Depression

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

Interventions

pregnenolone

placebo

Study Details

Brief summary:

This study aims to identify how enhanced allopregnanolone activity (via pregnenolone) affects behavior and neurobiology that may underlie perimenopausal depression.

Conditions

Depression

Study ID

NCT06238700

Start date

May 1, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: pregnenolone

Participants will take 250mg of pregnenolone twice per day (daily total=500mg) for four weeks

placebo comparator: placebo

Participants will take placebo twice per day for four weeks

Interventions

pregnenolone

Pregnenolone is an endogenous steroid available in the US and elsewhere as an orally administered over-the-counter supplement.

placebo

Placebo pills are identical-appearing capsules containing cellulose

Primary outcome measure

  • Within-person change in score on the Ruminative Responses Scale [ Time Frame: Baseline to 2 weeks ]

Central Contacts and Locations

Central contacts

Aleta Wiley, MPH

617-975-8706awiley3@bidmc.harvard.edu

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Aug 26, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-08-26.