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

a study on Post-Traumatic Stress Disorder Stress

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)

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

You can join if…

Open to people ages 18-69

  • 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 CAN'T join 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

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

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