Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: PTSD
In brief
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.
Key facts
- Study ID
- NCT04452500
- Run by
- VA Office of Research and Development
- People needed
- 40
- Starts
- 2022-10-15
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-01-29
Who can join
Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States (enrolling)
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (enrolling)
Full record on ClinicalTrials.gov
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