Actively Recruiting
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
Led by VA Office of Research and Development · Updated on 2026-01-29
40
Participants Needed
2
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- History of US military service
- Able to read and understand English
- Able to provide written informed consent
- Symptoms of PTSD with a CAPS-5 score of 23 or greater at screening
- Men and pre-menopausal women must agree to use two forms of reliable contraception, including one barrier method
- Stable dose of SSRI or SNRI medication for PTSD for at least 8 weeks prior to enrollment
- Stable dose of trazodone for sleep if used
- Stable dose of opiate pain medication if used
- Stable psychotherapy treatment for at least 6 weeks if applicable
You will not qualify if you...
- Alcohol use meeting criteria for Alcohol Use Disorder within the past 3 months
- Marijuana or other drug use meeting criteria for Substance Use Disorder within the past 3 months
- Diagnosis of 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
- Current use of antidepressants such as doxepin or tricyclics
- Current use of mood stabilizers like lithium
- Current use of antipsychotic medication
- High risk for suicide or violent behavior
- Untreated sleep apnea
- Current use of corticosteroid medication (oral or inhaled)
- History of neurological disease
- History of angina, congestive heart failure, or low blood pressure
- Heart attack within 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 abnormal AST or ALT labs
- History of kidney disease with low eGFR
- Additional risk factors for Torsades de pointes
- Use of medications affecting heart rhythm or interfering with study drug
- Uncontrolled high blood pressure
- Poorly controlled diabetes
- History of certain head injuries
- Mild cognitive impairment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
Actively Recruiting
2
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
Actively Recruiting
Research Team
J
Jennifer A Hlavin, MS
CONTACT
S
Stephanie Menjivar Quijano, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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