RECRUITING

Study on Allopregnanolone and Depression in Women Across the Menopause Transition

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Conditions

Depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2024-05-14
Study Completion:2027-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06238700

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.

Ages Eligible for Study:40 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Healthy women ages 40 to 60 years in the menopause transition
  2. * Depressive symptoms
  3. * Psychotropic medications are allowed if the dose is stable prior to screening and throughout the study
  4. * Able to read Arabic numerals and perform simple arithmetic
  5. * Able to provide written informed consent
  1. * Systemic hormone therapy
  2. * Contraindicated medications with pregnenolone
  3. * Systemic corticosteroid
  4. * Other psychiatric illnesses that are considered to be primary
  5. * Current suicidal ideation
  6. * Active substance use disorders
  7. * Unstable medical conditions
  8. * Obstructive sleep apnea or other primary sleep disorders
  9. * Abnormal hepatic and renal function
  10. * Known allergy to progesterone, exogenous allopregnanolone, or pregnenolone
  11. * History of head injury resulting in loss of consciousness \> 20 min
  12. * Inability to comply with barrier contraceptive methods
  13. * Known intellectual disability
  14. * Investigator judgement that study participation constitutes substantial risk given medical or psychiatric condition
  15. * Current or recent participation in clinical trial expected to interfere with risk of or interpretation of study data
  16. * Inability to comply with study procedures

Contacts and Locations

Study Contact

Aleta Wiley, MPH
CONTACT
617-525-9627
awiley1@bwh.harvard.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-14
Study Completion Date2027-08-31

Study Record Updates

Study Start Date2024-05-14
Study Completion Date2027-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Depression