Identifying neural mechanisms of PTSD symptom reduction induced by combined estrogen and prolonged exposure therapy.

Brief description of study

The purpose of this research study is to determine if taking a pill of estradiol (a form of estrogen) together with prolonged exposure (PE) therapy can improve this treatment outcome in women diagnosed with Post- Traumatic Stress Disorder (PTSD). PTSD is a mental health disorder that some people develop after witnessing or experiencing a traumatic event. People who have PTSD re-experience the traumatic event and feel the same fear and discomfort that they associated with the trauma long after the danger has gone. Prolonged Exposure (PE) therapy is a validated treatment for PTSD. However, while this therapy is a first- line, evidence-based treatment for PTSD, some people with PTSD do not fully recover after receiving PE therapy and others do not benefit at all from this treatment. This has driven researchers to find ways to improve the treatment. Based on previous findings that the hormone known as estrogen facilitates people learning not to fear things they had feared before, we want to supplement prolonged exposure therapy with an estradiol pill given before each therapy session. We expect estradiol to increase the effects of the therapy. The use of estradiol is not approved by the U.S. Food and Drug Administration to treat PTSD but experimental research like the present study is needed to test if it is beneficial.

Clinical Study Identifier: s19-01051 Identifier: NCT03371654
Principal Investigator: Mohammed R Milad.
Other Investigator: Naomi M. Simon.

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