Recruiting
Phase 2

Selective Glucocorticoid Receptor Antagonist

Sponsor:

VA Office of Research and Development

Code:

NCT04452500

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

CORT108297

Placebo

Study Details

Brief 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.

Conditions

PTSD

Study ID

NCT04452500

Start date

Oct 15, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CORT108297

CORT108297- 180mg daily for 7 days

placebo comparator: Placebo

Placebo- 180mg daily for 7 days

Interventions

CORT108297

CORT108297- 180mg daily for 7 days

Placebo

Placebo- 180mg daily for 7 days

Primary outcome measure

  • Clinician Administered PTSD Scale for DSM-5 (CAPS) [ Time Frame: 56 days ]
  • Frequency, Intensity, Burden of Side Effects (FIBSER) [ Time Frame: 56 days ]

Central Contacts and Locations

Central contacts

Jennifer A Hlavin, MS

(415) 221-4810jennifer.hlavin@va.gov

Stephanie Menjivar Quijano, BA

(415) 802-5308stephanie.menjivarquijano@va.gov

Locations

Tuscaloosa VA Medical Center, Tuscaloosa, AL

Recruiting

Tuscaloosa, Alabama, United States, 35404

Contacts

Brittney Washington

205-554-2000Brittney.washington@va.gov

Whitney Gay

2055542000Whitney.gay@va.gov

San Francisco VA Medical Center, San Francisco, CA

Recruiting

San Francisco, California, United States, 94121-1563

Contacts

Jennifer A Hlavin, MS

415-221-4810jennifer.hlavin@va.gov

Principal Investigator:

Thomas C. Neylan, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 29, 2026

Last verified

Jan, 2026

Keywords

  • Glucocorticoids
  • Posttraumatic Stress Disorder
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-29.