Optic

ID

Name

IRB00103595

Description

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.

Trial arms

Trial start

2019-11-11

Estimated PCD

2024-08-01

Trial end

2024-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Estradiol patch

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

Arms:

Cohort 1: Healthy Controls Receiving Estradiol then Placebo, Cohort 1: Healthy Controls Receiving Placebo then Estradiol, Cohort 1: PTSD Receiving Estradiol then Placebo, Cohort 1: PTSD Receiving Placebo then Estradiol, Cohort 1: Trauma without PTSD Receiving Estradiol then Placebo, Cohort 1: Trauma without PTSD Receiving Placebo then Estradiol, Cohort 2: Healthy Control Receiving Estradiol then Placebo, Cohort 2: Healthy Control Receiving Placebo then Estradiol, Cohort 2: PTSD Receiving Estradiol then Placebo, Cohort 2: PTSD Receiving Placebo then Estradiol, Cohort 2: Trauma Control Receiving Estradiol, then Placebo, Cohort 2: Trauma Control Receiving Placebo then Estradiol

Placebo patch

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

Arms:

Cohort 1: Healthy Controls Receiving Estradiol then Placebo, Cohort 1: Healthy Controls Receiving Placebo then Estradiol, Cohort 1: PTSD Receiving Estradiol then Placebo, Cohort 1: PTSD Receiving Placebo then Estradiol, Cohort 1: Trauma without PTSD Receiving Estradiol then Placebo, Cohort 1: Trauma without PTSD Receiving Placebo then Estradiol, Cohort 2: Healthy Control Receiving Estradiol then Placebo, Cohort 2: Healthy Control Receiving Placebo then Estradiol, Cohort 2: PTSD Receiving Estradiol then Placebo, Cohort 2: PTSD Receiving Placebo then Estradiol, Cohort 2: Trauma Control Receiving Estradiol, then Placebo, Cohort 2: Trauma Control Receiving Placebo then Estradiol

Size

240

Primary endpoint

Change in amygdala response to fearful faces stimuli

Mid-cycle second cycle, Mid-cycle third cycle (each cycle is an average of 28 days)

Change in amygdala response to fear conditioning task

Mid-cycle second cycle, Mid-cycle third cycle (each cycle is an average of 28 days)

Change in ventromedial prefrontal cortex (vmPFC) activation during the fear extinction task

Mid-cycle second cycle, Mid-cycle third cycle (each cycle is an average of 28 days)

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Women will participate in one cycle with the estrogen patch and one cycle with the placebo patch. Each cohort will include 40 participants in each of the three study arms for a total of 240 participants.', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Randomization will be double blind, with the key held by the study coordinator in a locked file. The study coordinator will do checks of appropriate enrollment to groups after each 20 participants, but no blind will be broken to individuals analyzing study data. Grady pharmacy services will also hold the randomization schedule, as they will dispense the appropriate patch at the appropriate time point.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

Updated at

2024-03-01

Organization

Product

Indication

Indication

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