Phase
Condition
Post-traumatic Stress Disorders
Treatment
Placebo oral tablet
Estradiol
Prolonged Exposure (PE) therapy
Clinical Study ID
Ages 18-45 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Female, 18-45 years of age
Chronic (at least one month post-trauma) DSM-5 FULL PTSD diagnosis OR subPTSDdiagnosis (subPTSD defined as: meeting criterion A, F, G, H, and clusters B, C, andat least 1 of the clusters D or E.)
CAPS-5 Past Month score ≥ 20
Criterion A traumatic event
Stable medications for 3 or more months by the time of study entrance (with theexception of benzodiazepines)
Women on oral contraceptives, specifically those using monophasic or biphasic offirst, second, third or fourth generation with up to 35mcg of ethinyl estradiol; ORusing etonogestrel / ethinyl estradiol 0.120mg/0.015mg per day vaginal ring birthcontrol; OR using the norelgestromin / ethinyl estradiol 0.150mg/0.035mg per daytransdermal patch birth control.
Willing and able to provide informed consent
Exclusion
Exclusion Criteria:
Diagnosis of bipolar I disorder with a past year manic episode
Diagnosis of a psychotic disorder or psychotic symptoms that would interfere withthe ability to focus on posttraumatic stress disorder (PTSD) in clinic, asdetermined by clinical judgment.
Diagnosis of moderate or severe substance use disorder that would interfere with theability to focus on posttraumatic stress disorder (PTSD) in clinic, as determined byclinical judgment.
Cognitive impairment that would interfere with the ability to focus on posttraumaticstress disorder (PTSD) in clinic, as determined by clinical judgment.
History of neurological disease (that involves the brain), seizure, or significanthead trauma (i.e., extended loss of consciousness, neurological sequelae, or knownstructural brain lesion).
Suicidal ideation with imminent risk that warrants a higher level of care.
Concurrent trauma focused psychotherapy
Pregnancy (to be ruled out by urine ß-HCG).
Metallic implants or devices contraindicating magnetic resonance imaging byinterfering with patient safety or fMRI data collection. Cases will be cleared bythe Principal Investigator and/or Baylor College of Medicine (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.
High risk of adverse emotional or behavioral reaction, and/or an inability tounderstand study procedures or the informed consent process, based oninvestigator/clinician clinical evaluation (e.g., evidence of serious personalitydisorder, antisocial behavior, serious current stressors, lack of meaningful socialsupport)
Study Design
Study Description
Connect with a study center
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania 19104
United StatesSite Not Available
The University of Texas Health Science Center at Houston (UTHealth Houston)
Houston, Texas 77054
United StatesSite Not Available
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