RecruitingPhase 2NCT04452500

Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)

Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)


Sponsor

VA Office of Research and Development

Enrollment

40 participants

Start Date

Oct 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new medication that blocks a specific stress hormone receptor in the brain to see if it can reduce PTSD symptoms in military veterans. Standard PTSD treatments don't work for everyone, so researchers are looking for new options. **You may be eligible if:** - You are a US military veteran with PTSD symptoms - You can read and understand English - If you take antidepressants (SSRIs or SNRIs) for PTSD, you have been on a stable dose for at least 8 weeks - If you are in therapy, your treatment has been stable for at least 6 weeks **You may NOT be eligible if:** - You have had alcohol use disorder, drug use disorder, or a substance use disorder in the past 3 months - You have been diagnosed with bipolar disorder, schizophrenia, or psychotic depression - You experienced a traumatic event in the last 3 months - You currently take antipsychotics, lithium, or certain older antidepressants - You have untreated sleep apnea - You currently use steroids (oral or inhaled) - You have significant heart, kidney, or liver problems - You have uncontrolled high blood pressure or diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCORT108297

CORT108297- 180mg daily for 7 days

DRUGPlacebo

Placebo- 180mg daily for 7 days


Locations(2)

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Tuscaloosa, Alabama, United States

San Francisco VA Medical Center, San Francisco, CA

San Francisco, California, United States

View Full Details on ClinicalTrials.gov

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NCT04452500


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