Study on Allopregnanolone and Depression in Women Across the Menopause Transition

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 andthroughout 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 givenmedical or psychiatric condition

• Current or recent participation in clinical trial expected to interfere with risk ofor interpretation of study data

• Inability to comply with study procedures