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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 26, 2020

Keywords

ClinConnect Summary

This clinical trial, called the Seven Study, is testing a new medication called CORT108297 to see if it can help veterans who are struggling with Posttraumatic Stress Disorder (PTSD). The drug works by blocking the hormone cortisol, which is often linked to stress. The goal of the study is to determine if this medication is safe and effective for treating PTSD, particularly in veterans who have served in the military.

To participate, individuals must be veterans, aged between 25 and 74, and have symptoms of PTSD, as measured by a specific assessment tool. They should also be able to read and understand English and provide written consent to join the study. Participants must be stable on certain medications for at least eight weeks before enrolling, and both men and women of childbearing age must agree to use two forms of contraception. It's important to note that some individuals, such as those with certain medical conditions or recent substance use issues, may not be eligible. Those who join can expect regular check-ins and assessments throughout the study to monitor their health and response to the medication.

Gender

ALL

Eligibility 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