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CORT108297 for PTSD in Veterans

This study is testing a drug called CORT108297, which is designed to block the stress hormone cortisol, to see if it can help Veterans with Posttraumatic Stress Disorder (PTSD). Researchers also want to understand its safety. You might be able to join if you are a Veteran between 18 and 69 years old, can read English, and have been diagnosed with PTSD. The study will measure how much your PTSD symptoms change using a special assessment called CAPS-5, and also track any side effects. The study's current status is unclear, but it plans to enroll 40 participants.

Study design
This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial involving 40 Veterans. Participants will receive either CORT108297 or a placebo for 7 days.
What's involved
You will undergo screening, including interviews, questionnaires, blood tests, and medical evaluations. If eligible, you will take the study drug or placebo for seven days, with several in-person and virtual visits before, during, and after this period.
Compensation
Not stated in the trial record.
Follow-up
Your PTSD symptoms and side effects will be measured at baseline, day 7, day 28, and day 56 after starting the study drug or placebo.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04452500

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

Recruiting
PHASE2Ages 18–69InterventionalTreatment
VA Office of Research and Development
~40 participants
Updated 2026-01-29 on ClinicalTrials.gov
What's tested:CORT108297Placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinician Administered PTSD Scale for DSM-5 (CAPS)
Measured over 56 days
+1 more outcome measured

Conditions

PTSD

Explore related trials

Post-Traumatic Stress Disorder

Where it's being run

2 sites across 2 states
Alabama1
California1

Study leadership

  • Thomas C. Neylan, MD · PRINCIPAL_INVESTIGATOR · San Francisco VA Medical Center, San Francisco, CA

Who to contact

Jennifer A Hlavin, MS
[email protected]
(415) 221-4810 · ext. 26624
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Clinician Administered PTSD Scale for DSM-5 (CAPS)56 days

    The CAPS is a 30-item interview that is the gold standard assessment for PTSD. The CAPS provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score.

  • Frequency, Intensity, Burden of Side Effects (FIBSER)56 days

    The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.