Neuroendocrine Risk for PTSD in Women

• Status: Recruiting
• Trial end date: 2024-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study will test for effects of estradiol (E2) on PTSD symptoms and functional magnetic resonance imaging (fMRI) indicators of stress vulnerability, in naturally-cycling women who are not using hormonal birth control. Enrollment will be targeted to create three groups within two cohorts (early follicular phase and luteal phase):

1. PTSD: Women who meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for PTSD

2. Trauma-Exposed (TC): Women matched for age and trauma exposure severity but without PTSD

3. Healthy Control (HC): Women matched for age, but without trauma history or psychiatric disorder (self-reported)

Women will be recruited through Grady Trauma Project (GTP), a large longstanding study of civilian trauma and PTSD conducted at Grady Memorial Hospital in Atlanta, Georgia.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Emory University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• African American women

• A menstrual period within the past 60 days

• Able and willing to give informed consent

• Must have a smart phone and willing to install the Clue app

Exclusion Criteria:

• Women currently taking any form of hormone-based birth control or other hormonal supplement

• Women who are pregnant or breastfeeding

• Current psychoactive medication use, nicotine use or smoking

• Hypercoagulable conditions, history of embolism, current symptoms of psychosis or bipolar disorder

• History of major head injury or neurological disorder

• Weight >250lbs (a maximum weight to allow for participants to fit comfortably inside the bore of the MRI machine) and typical physical contraindications for MRI such as metal implants