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Neuroendocrine Risk for PTSD in Women
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.
Conditions:
🦠 PTSD 🦠 Trauma
🗓️ Study Start (Actual) 11 November 2019
🗓️ Primary Completion (Estimated) August 2024
✅ Study Completion (Estimated) August 2024
👥 Enrollment (Estimated) 240
🔬 Study Type INTERVENTIONAL
📊 Phase EARLY_PHASE1
Locations:
📍 Atlanta, Georgia, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 35 Years (ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 30 May 2019
  • First Submitted that Met QC Criteria 3 June 2019
  • First Posted 4 June 2019

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 February 2024
  • Last Update Posted 1 March 2024
  • Last Verified February 2024
I'm interested ...!!