Summary

Eligibility
for people ages 18-69 (full criteria)
Location
at UCSF
Dates
study started
completion around
Principal Investigator
by Thomas C. Neylan, MD (ucsf)
Headshot of Thomas C. Neylan
Thomas C. Neylan

Description

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.

Official Title

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

Details

This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study drug or placebo for seven days. The key outcome measures will be obtained at baseline, day 7, 28, and day 56.

There is large body of evidence demonstrating that Posttraumatic Stress Disorder (PTSD) is associated with alterations in the stress hormone cortisol. There is also evidence that medications that block cortisol may be beneficial for treating PTSD and depression. This study will test a medication, CORT108297, which is from a new class of cortisol blockers which have no effect on other hormones. CORT108297 has been shown to have efficacy in preclinical CNS models and was well tolerated and safe in Phase I healthy volunteer studies making it a candidate for further development. Thus, the goal will be to complete a Phase IIa proof of concept trial of CORT108297 to focus on safety and tolerability and obtain pilot efficacy data to inform the design of future clinical trials.

Keywords

PTSD, Glucocorticoids, Posttraumatic Stress Disorder, Quality of Life, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, CORT108297

Eligibility

Locations

  • San Francisco VA Medical Center, San Francisco, CA accepting new patients
    San Francisco California 94121-1563 United States
  • Tuscaloosa VA Medical Center, Tuscaloosa, AL accepting new patients
    Tuscaloosa Alabama 35404 United States

Lead Scientist at University of California Health

  • Thomas C. Neylan, MD (ucsf)
    Dr. Neylan is a Professor, In Residence in the Departments of Psychiatry and Neurology at the University of California, San Francisco. He is the Director of the Posttraumatic Stress Disorders (PTSD) Clinic and the Stress and Health Research Program at the San Francisco Veterans Affairs Medical Center.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
VA Office of Research and Development
ID
NCT04452500
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 88 study participants
Last Updated