Neuroendocrine Risk for PTSD in Women

Completed · Early Phase 1 · Has a placebo group

Conditions studied: PTSD, Trauma

In brief

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.

Key facts

Study ID

NCT03973229

Run by

Emory University

People needed

127

Starts

2019-11-11

Expected to finish

2025-04-30

Last updated by the study team

2026-07-22

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Grady Memorial Hospital — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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