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New treatment option for PTSD
Official title Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
ClinicalTrials.gov ID: NCT04452500
What this study is testing
What is CORT108297?
CORT108297 is an investigational medicine, given as an once-daily, being studied as a potential treatment for ptsd.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tuscaloosa, Alabama, United States
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tuscaloosa, Alabama, United States; San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.