VA Office of Research and Development
The purpose of this study is to test the drug CORT108297, which blocks the hormone cortisol, for treatment of PTSD in Veterans, and establish a safety profile that will inform the design of future studies.
This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study…
Inclusion Criteria: * History of US military service * Capable of reading and understanding English * Able to provide written informed consent * Symptoms of PTSD (must score 23 or greater on the CAPS-5 assessment at screening visit) * Men and pre-menopausal women must agree to use two forms of reliable contraception, one of which is a barrier method. * Participants who use an SSRI or SNRI medication for PTSD must be on a stable dose for 8 weeks before enrollment. * Participants who use trazodone for sleep must be on a stable dose. * Participants who use opiate pain medication must be on a sta…
CORT108297- 180mg daily for 7 days
Placebo- 180mg daily for 7 days
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