A Randomized, Double-blind Placebo-controlled Multi-center Study of Identifying Neural Mechanisms of PTSD Symptom Reduction Induced by Combined Estrogen and Prolonged Exposure Therapy

19-01051

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.

2020-06-24

2024-07-31

2024-07-31

Recruiting

Early phase I

80

Inclusion Criteria: 1. Female, 18-45 years of age 2. Chronic (at least one month post-trauma) DSM-5 PTSD symptoms 3. CAPS-5 Past Month score ≥ 26 4. Criterion A traumatic event 5. Stable medications for 3 or more months by the time of study entrance (with the exception of benzodiazepines) 6. 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; OR using the norelgestromin / ethinyl estradiol 0.150mg/0.035mg per day transdermal patch birth control. 7. Willing and able to provide informed consent Exclusion Criteria: 1. Diagnosis of bipolar I disorder with a past year manic episode 2. 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. 3. 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. 4. Cognitive impairment that would interfere with the ability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined by clinical judgment. 5. History of neurological disease (that involves the brain), seizure, or significant head trauma (i.e., extended loss of consciousness, neurological sequelae, or known structural brain lesion). 6. Suicidal ideation with imminent risk that warrants a higher level of care. 7. Concurrent trauma focused psychotherapy 8. Pregnancy (to be ruled out by urine ß-HCG). 9. 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 10. History of breast cancer or hormone-responsive cancer. 11. Use of benzodiazepines 12. Self-injurious behavior that involves suicidal intent, requires medical attention, or occurs daily.

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2023-02-01