Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
NCT ID: NCT04452500
Last Updated: 2026-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2022-10-15
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CORT108297
CORT108297- 180mg daily for 7 days
CORT108297
CORT108297- 180mg daily for 7 days
Placebo
Placebo- 180mg daily for 7 days
Placebo
Placebo- 180mg daily for 7 days
Interventions
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CORT108297
CORT108297- 180mg daily for 7 days
Placebo
Placebo- 180mg daily for 7 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
69 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Thomas C. Neylan, MD
Role: PRINCIPAL_INVESTIGATOR
San Francisco VA Medical Center, San Francisco, CA
Locations
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Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CX001917-01
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
MHBB-014-18S
Identifier Type: -
Identifier Source: org_study_id
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