Study on Allopregnanolone and Depression in Women Across the Menopause Transition

ConditionDepression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorBeth Israel Deaconess Medical Center

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

Systemic hormone therapy

Contraindicated medications with pregnenolone

Systemic corticosteroid

Other psychiatric illnesses that are considered to be primary

Trial design

Treatments tested in this trial

  • pregnenolone
  • placebo

Treatment groups

80 Participants
are divided into 2 treatment groups