Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Description

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

Conditions

Depression

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Study Overview

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Study Details

Study overview

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

Targeting Allopregnanolone to Probe Behavioral and Neurobiological Mechanisms That Underlie Depression in Women Across the Menopause Transition

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

Condition
Depression
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

40 Years to 60 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Hadine Joffe, MD MSc, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Katherine Burdick, PhD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2027-08-31