Estrogen and Fear in PTSD

  • STATUS
    Recruiting
  • End date
    Dec 3, 2022
  • participants needed
    80
  • sponsor
    NYU Langone Health
Updated on 3 February 2021
benzodiazepines

Summary

The purpose of this research study is to determine if taking a pill of estradiol (E2) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post-Traumatic Stress Disorder (PTSD). 80 subjects will take part in this research study across NYU Langone Health and UPenn (40 subjects at each site). Participants will be randomized into one of two groups, PE + E2 or PE + placebo. The study will include preliminary screening and baseline visits, experimental visits, and therapy visits over the course of six weeks. Several follow-up visits will take place.

Description

Prolonged-exposure (PE) therapy is the treatment of choice for posttraumatic stress disorder (PTSD). Despite its efficacy, a significant number of individuals will not benefit from it or might drop out before the completion of all sessions. This underlies the importance of findings ways to enhance the efficacy of PE in order to improve the life quality of individuals suffering from PTSD. It is now widely accepted that extinction learning paradigms used in fundamental studies are useful laboratory analogs to PE. Studies in healthy controls have suggested that elevated estrogen levels benefit extinction learning by promoting its consolidation and thus enhancing its recall when tested later for it. This is also being reflected by changes in the activation of brain regions forming the fear extinction network, including the amygdala, dorsal anterior cingulate cortex (dACC) and ventromedial prefrontal cortex (vmPFC). It is still unknown whether estradiol (E2) administration can modulate the activation of the fear extinction network in oral contraceptive (OC) users and which E2 dose could yield the best results. During the R61 phase of the study, we found that both doses of E2 were effective in engaging the functional activation of the fear extinction network. Therefore, we will use the lower dose (2mg) for the R33 phase. We will combine E2 administration with PE sessions to see if administration of PE can significantly improve clinical outcomes (reduced PTSD symptoms) and engage the fear extinction network in the brain.

Hypothesis: A general improvement is expected after 3 weeks of treatment in both groups given the anticipated benefits of PE alone. But the benefit of the Estradiol-treated groups is hypothesized be larger; with this group exhibiting significantly higher activation in brain regions associated with fear extinction. This will be noted at the follow-up scan compared to the baseline scan.

PTSD symptom severity expected be significantly lower in the Estradiol and PE group relative to the Placebo+PE group following acute treatment after three weeks of treatment.

The degree of PTSD symptom reduction post- compared to pre-PE after 3 weeks of treatment is expected be associated with BOLD changes in the fear extinction network and reduction in SCR during the extinction recall test after PE. The magnitude of BOLD and SCR changes will be significantly larger in the E2+PE group compared to the Plc+PE group.

Details
Condition Post-Traumatic Stress Disorder, Post-Traumatic Stress Disorders, PTSD
Treatment Estradiol, Placebo Oral Tablet
Clinical Study IdentifierNCT04192266
SponsorNYU Langone Health
Last Modified on3 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 45 yrs?
Are you female?
Do you have any of these conditions: Post-Traumatic Stress Disorders or Post-Traumatic Stress Disorder?
Do you have any of these conditions: PTSD or Post-Traumatic Stress Disorder or Post-Traumatic Stress Disorders?
Do you have any of these conditions: Post-Traumatic Stress Disorders or Post-Traumatic Stress Disorder or PTSD?
Female, 18-45 years of age
Chronic (at least one month post-trauma) DSM-5 PTSD symptoms
CAPS-5 Past Month score 26
Criterion A traumatic event
Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines)
Women on oral contraceptives, specifically those using monophasic or biphasic of first, second, third or fourth generation with up to 35mcg of ethinyl estradiol; OR using etonogestrel / ethinyl estradiol 0.120mg/0.015mg per day vaginal ring (NuvaRing) birth control
Willing and able to provide informed consent

Exclusion Criteria

Diagnosis of bipolar I disorder with a past year manic episode
Diagnosis of a psychotic disorder or psychotic symptoms that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment
Diagnosis of moderate or severe substance use disorder that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment
Cognitive impairment that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment
Suicidal ideation with imminent risk that warrants a higher level of care
Concurrent trauma focused psychotherapy
Pregnancy (to be ruled out by urine -HCG)
Metallic implants or devices contraindicating magnetic resonance imaging by interfering with patient safety or fMRI data collection. Cases will be cleared by the Principal Investigator and Center for Brain Imaging
History of breast cancer or hormone-responsive cancer
Use of benzodiazepines
Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily
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