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Corticosteroid

Glucocorticoid Receptor Antagonist for PTSD (SEVEN Trial)

Phase 2
Recruiting
Led By Thomas C. Neylan, MD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants may be on a stable dose (8 weeks at minimum) of an SSRI or SNRI for treatment of their PTSD
Participants (male or pre-menopausal females) agree to use two forms of reliable contraception, one of which is a barrier method
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 56 days
Awards & highlights

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.

Who is the study for?
This trial is for US veterans with PTSD from military service, including combat or sexual trauma. They must have had symptoms for over 3 months and agree to use two forms of contraception if applicable. Participants can be on stable doses of certain medications like trazodone or SSRIs/SNRIs but not others that affect the study drug's metabolism or increase suicide risk.Check my eligibility
What is being tested?
The trial is testing CORT108297, a new medication that blocks cortisol without affecting progesterone, which could help treat PTSD. It compares this drug to a placebo (a substance with no active drug). The goal is to see if it's effective and safe for treating PTSD in veterans.See study design
What are the potential side effects?
While the specific side effects are not listed here, similar drugs often cause hormonal imbalances, mood changes, increased blood sugar levels, possible heart rhythm problems (due to QTc prolongation), and interactions with other medications.

SEVEN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on a stable dose of medication for PTSD for at least 8 weeks.
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I agree to use two reliable birth control methods, including a barrier method.
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I have been diagnosed with PTSD for over 3 months and my recent CAPS-5 score is above 26.
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I am taking a stable dose of trazodone for sleep.
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My pain medication dose has been the same for at least 4 weeks.
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My psychotherapy treatment has been stable for at least 6 weeks.

SEVEN Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~56 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 56 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinician Administered PTSD Scale for DSM-5 (CAPS)
Frequency, Intensity, Burden of Side Effects (FIBSER)
Secondary outcome measures
Columbia Suicide Severity Rating Scale
PTSD Checklist for DSM-5
World Health Organization Quality of Life (WHOQOL-BREF)

SEVEN Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CORT108297Experimental Treatment1 Intervention
CORT108297- 180mg daily for 7 days
Group II: PlaceboPlacebo Group1 Intervention
Placebo- 180mg daily for 7 days

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,606 Previous Clinical Trials
3,305,917 Total Patients Enrolled
Thomas C. Neylan, MDPrincipal InvestigatorSan Francisco VA Medical Center, San Francisco, CA
3 Previous Clinical Trials
257 Total Patients Enrolled

Media Library

CORT108297 (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT04452500 — Phase 2
Post-Traumatic Stress Disorder Research Study Groups: Placebo, CORT108297
Post-Traumatic Stress Disorder Clinical Trial 2023: CORT108297 Highlights & Side Effects. Trial Name: NCT04452500 — Phase 2
CORT108297 (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04452500 — Phase 2
Post-Traumatic Stress Disorder Patient Testimony for trial: Trial Name: NCT04452500 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Are individuals younger than thirty eligible for this experiment?

"This clinical trial has an age range criterion of 18 to 69 years old."

Answered by AI

Who else is applying?

What state do they live in?
Mississippi
California
What site did they apply to?
San Francisco VA Medical Center, San Francisco, CA
Tuscaloosa VA Medical Center, Tuscaloosa, AL
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+

Why did patients apply to this trial?

I’ve been treating my ptsd for a lot time with medication here and there. I’m willing to try something else.
PatientReceived 1 prior treatment
~30 spots leftby Dec 2024