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Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
RecruitingPhase 2
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
Who can join
Ages 18 to 69 · All sexes
Full eligibility criteria
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 stable dose. * For participants who are in psychotherapy, treatment must be stable for 6 weeks. Exclusion Criteria: * Alcohol use that meets criteria for Alcohol Use Disorder in past 3 months. * Marijuana or other drug use that meets criteria for Substance Use Disorder in past 3 months. * Ever diagnosed with: Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Obsessive-Compulsive Disorder, or Major Depressive Disorder with Psychotic Features * Experienced any psychologically traumatic event in the past 3 months * Currently using certain antidepressant medications such as doxepin or tricyclics * Currently using certain mood stabilizers, such as lithium * Currently using antipsychotic medication * High risk for suicide or violent behavior * Has sleep apnea and not using any treatment, such as CPAP * Currently using corticosteroid medication (oral or inhaled) * History of neurological disease * Angina, congestive heart failure or low blood pressure * Heart attack in the past 6 months * Heart block or irregular heartbeat * Kidney failure, liver failure or pancreatitis * Severe chronic obstructive pulmonary disease (COPD) * History of liver disease with lab results on AST or ALT more than 2 times the normal readings * History of kidney disease with lab results on eGFR less than 60 ml/min * History of additional risk factors for Torsades de pointes, such as heart failure, low potassium, or family history of a heart rhythm disorder called long QT syndrome * Use of certain medications that can affect heart rhythm * Use of certain medications that can interfere with the effects of the study drug * High blood pressure that is not controlled by medication * Diabetes that is not well-controlled * History of certain types of head injuries * Mild cognitive impairment
About the study
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.
What is being tested
- CORT108297 (drug)
- Placebo (drug)
Sponsor: VA Office of Research and Development · Participants: 40 · Started: Oct 15, 2022
Contact the study team
- Jennifer A Hlavin, MS · Phone: (415) 221-4810
- Stephanie Menjivar Quijano, BA · Phone: (415) 802-5308
Official record on ClinicalTrials.gov — NCT04452500
Locations in the U.S.
| Alabama | Tuscaloosa VA Medical Center, Tuscaloosa, AL, Tuscaloosa |
| California | San Francisco VA Medical Center, San Francisco, CA, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.