Testing a new drug for PTSD in veterans
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
This study is testing a new drug for PTSD to see if it can help veterans feel better after a week of treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 2 sites (Tuscaloosa, Alabama and 1 other locations) |
| Trial ID | NCT04452500 on ClinicalTrials.gov |
What this trial studies
This Phase IIa clinical trial aims to evaluate the safety and efficacy of CORT108297, a selective glucocorticoid receptor antagonist, in treating PTSD symptoms among veterans. The study involves a randomized, double-blind, placebo-controlled design where participants will receive either the drug or a placebo for seven days. Veterans will undergo screening procedures, including psychological interviews and medical evaluations, and will be monitored through several follow-up visits to assess changes in PTSD symptoms. The trial seeks to gather pilot efficacy data to inform future studies on this treatment approach.
Who should consider this trial
Good fit: Ideal candidates are veterans with chronic PTSD who meet specific eligibility criteria, including a minimum score on the CAPS-5 assessment.
Not a fit: Patients with a history of certain psychiatric disorders or substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for veterans suffering from PTSD.
How similar studies have performed: Previous studies have indicated that cortisol-blocking medications may be beneficial for treating PTSD, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Tuscaloosa, Alabama and 1 other locations
- Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama, United States (Recruiting)
- San Francisco VA Medical Center, San Francisco, CA — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Thomas C. Neylan, MD — San Francisco VA Medical Center, San Francisco, CA
- Study coordinator: Jennifer A Hlavin, MS
- Email: jennifer.hlavin@va.gov
- Phone: (415) 221-4810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.