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Glucocorticoid Receptor Antagonist for PTSD (SEVEN Trial)
SEVEN Trial Summary
This trial will test a new drug to see if it can help people with PTSD by blocking the stress hormone cortisol.
SEVEN Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSEVEN Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SEVEN Trial Design
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Who is running the clinical trial?
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- You have been diagnosed with alcohol, marijuana, or drug addiction in the last 3 months according to the DSM-5 guidelines.I am not taking certain antidepressants, mood stabilizers, antipsychotics, or benzodiazepines.I have been on a stable dose of medication for PTSD for at least 8 weeks.You have experienced any kind of injury or accident within the past 3 months.It's okay if you drink alcohol or use marijuana occasionally, as long as you don't have a problem with addiction.I agree to use two reliable birth control methods, including a barrier method.I have a brain disorder or illness affecting my brain function.I have been diagnosed with PTSD for over 3 months and my recent CAPS-5 score is above 26.I am taking a stable dose of trazodone for sleep.I am taking a stable dose of trazodone for sleep.I have untreated sleep apnea or tested positive for it recently.My pain medication dose has been the same for at least 4 weeks.My pain medication dose has been the same for at least 4 weeks.You have been diagnosed with severe mental illnesses like bipolar disorder, schizophrenia, or major depression with psychotic features.My psychotherapy treatment has been stable for at least 6 weeks.I have not had serious thoughts or actions of harming myself or others in the last 3 months.I need to take corticosteroids for my medical condition.
- Group 1: Placebo
- Group 2: CORT108297
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the Food and Drug Administration sanctioned CORT108297?
"From 1 to 3, our analysts have assigned CORT108297 a score of 2 due to existing data which supports its safety but not yet efficacy."
What is the magnitude of individuals being observed in this clinical investigation?
"Affirmative. According to the records on clinicaltrials.gov, this medical trial is presently enrolling patients since it was first posted on October 15th 2022 and last updated a few days later. The research requires 88 participants from 2 distinct sites."
Who meets the criterion to partake in this clinical experimentation?
"This clinical research is available to 88 adults aged between 18 and 69 who are suffering from moral injury. Moreover, those partaking must adhere to the following conditions: contraceptive methods (including barrier options) for male/pre-menopausal female participants; a diagnosis of PTSD that has been present for more than three months as measured by CAPS-5 at screening and a total score on this assessment exceeding 26 in the week preceding baseline testing; prior US military service; if engaging with psychotherapy, ensuring stability over six weeks."
Are there any available openings in this clinical experiment?
"This trial, initially posted on October 15th 2022 and recently edited on the 19th of same month is presently enrolling participants as indicated by clinicaltrials.gov."
Are individuals younger than thirty eligible for this experiment?
"This clinical trial has an age range criterion of 18 to 69 years old."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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