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COMPLETED
NCT03973229
EARLY_PHASE1

Neuroendocrine Risk for PTSD in Women

Sponsor: Emory University

View on ClinicalTrials.gov

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.

Official title: The LOW E2 STUDY- Neuroendocrine Risk Mechanisms for Post-traumatic Stress Disorder in Women

Key Details

Gender

FEMALE

Age Range

18 Years - 35 Years

Study Type

INTERVENTIONAL

Enrollment

127

Start Date

2019-11-11

Completion Date

2025-04-30

Last Updated

2026-07-22

Healthy Volunteers

No

Conditions

Interventions

DRUG

Estradiol patch

Estradiol (E2) patches at a dose of 100ug will be applied 24-48 hours before the MRI scan is performed.

OTHER

Placebo patch

Placebo patch identical to the estradiol patch will be applied 24-48 hours before the MRI scan is performed.

Locations (1)

Grady Memorial Hospital

Atlanta, Georgia, United States