Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
VA Office of Research and Development
Summary
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.
Description
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…
Eligibility
- Age range
- 18–69 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCORT108297
CORT108297- 180mg daily for 7 days
- DrugPlacebo
Placebo- 180mg daily for 7 days
Locations (2)
- Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosa, Alabama
- San Francisco VA Medical Center, San Francisco, CASan Francisco, California