Status:
RECRUITING
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
Lead Sponsor:
VA Office of Research and Development
Conditions:
PTSD
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
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 stu...
Detailed Description
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 sit...
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
Key Trial Info
Start Date :
October 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT04452500
Start Date
October 15 2022
End Date
December 31 2025
Last Update
January 14 2025
Active Locations (2)
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1
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States, 35404
2
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563