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

MHBB-014-18S

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.

2022-10-15

2024-12-31

2024-12-31

Recruiting

Early phase I

88

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

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2024-02-14