PTSDPhase 2SEVENNCT04452500
Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
A Phase 2 study testing CORT108297 in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- PTSD
- What is being tested?
- CORT108297
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2022to 31 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of US military service
- Capable of reading and understanding English
- Able to provide written informed consent
- Symptoms of post-traumatic stress disorder (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
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 25Show fewer
- Currently using antipsychotic medication
- High risk for suicide or violent behavior
- Has sleep apnea and not using any treatment, such as continuous positive airway pressure (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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404
About this study
Official title: Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180 milligrams daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study drug or placebo for seven days. The key outcome measures will be obtained at baseline, day 7, 28, and day 56.
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
- PTSD
- Being tested
- CORT108297, Placebo
- Keywords
- Glucocorticoids, Posttraumatic Stress Disorder, Quality of Life
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CORT108297Drug
CORT108297- 180 milligrams (mg) daily for 7 days
PlaceboDrug
Placebo- 180 milligrams (mg) daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| CORT108297 | Experimental | CORT108297- 180 milligrams (mg) daily for 7 days Receives: Drug: CORT108297 |
| Placebo | Placebo comparator | Placebo- 180 milligrams (mg) daily for 7 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale for DSM-5 (CAPS)
The CAPS is a 30-item interview that is the gold standard assessment for PTSD. The CAPS provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score.
Measured: 56 days
Frequency, Intensity, Burden of Side Effects (FIBSER)
The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.
Measured: 56 days
Secondary outcomes (3)
Columbia Suicide Severity Rating Scale
The C-SSRS is FDA approved for assessing severity and change of suicidality in drug studies.
Measured: 56 days
PTSD Checklist for DSM-5
The PCL is a validated self-report scale assessing PTSD symptoms corresponding to DSM-5.
Measured: 56 days
World Health Organization Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original WHOQOL-100 instrument and is more convenient for use in large research studies or clinical trials.
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start15 Oct 2022
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigators propose a two-site parallel group, randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Thomas C. Neylan, MD, Principal investigator, San Francisco VA Medical Center, San Francisco, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452500
- Sponsor's protocol ID
- MHBB-014-18S
- Other IDs
- 5I01CX001917-02, CX001917-01
- Acronym
- SEVEN
- Status last verified
- Oct 2026
- First submitted
- 26 Jun 2020
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For the proposed work final de-identified data from this project will be shared as widely as possible with the scientific community using UCSF DataShare (aka Dash). This self-service tool, available to any UCSF affiliated researcher, is a collaboration between University of California San Francisco's Library, and the UC Curation Center (UC3) at the California Digital Library and the UCSF Clinical and Translational Science Institute (CTSI).
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT04452500
- Acronym / sponsor ID
- SEVEN / MHBB-014-18S
- Conditions
- PTSD
- Keywords
- Glucocorticoids, Posttraumatic Stress Disorder, Quality of Life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180 milligrams daily for 7 days for PTSD symptoms in Veterans. Each of the two sites will enroll 44 Veterans with chronic PTSD. Participants first will undergo screening procedures, including a clinical psychological interview, self-report questionnaires, blood draw, and medical evaluations. If eligible, they will be randomized to either CORT108297 or placebo. The same procedures will be repeated at several in-person and virtual visits before, during and after taking the study drug or placebo for seven days. The key outcome measures will be obtained at baseline, day 7, 28, and day 56.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators propose a two-site parallel group, randomized, double-blind, placebo-controlled Phase IIa clinical trial to test the efficacy and safety of CORT108297- 180mg daily for 7 days for PTSD symptoms in Veterans.
| Arm | Type | Receives |
|---|---|---|
| CORT108297 | Experimental | Drug: CORT108297CORT108297- 180 milligrams (mg) daily for 7 days |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo- 180 milligrams (mg) daily for 7 days |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- History of US military service
- Capable of reading and understanding English
- Able to provide written informed consent
- Symptoms of post-traumatic stress disorder (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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CORT108297CORT108297- 180 milligrams (mg) daily for 7 days | Drug | CORT108297 |
| PlaceboPlacebo- 180 milligrams (mg) daily for 7 days | Drug | Placebo |
Primary outcome
Clinician Administered PTSD Scale for DSM-5 (CAPS)
Time frame: 56 days
The CAPS is a 30-item interview that is the gold standard assessment for PTSD. The CAPS provides a dimensional and categorical measure of PTSD, and incorporates frequency and intensity of symptoms into a single severity score.
Frequency, Intensity, Burden of Side Effects (FIBSER)
Time frame: 56 days
The FIBSER is a self-report 0-6 Likert-type scale that measures global frequency, intensity, and overall burden of side effects.
3 secondary outcomes
Columbia Suicide Severity Rating Scale
Time frame: 56 days
PTSD Checklist for DSM-5
Time frame: 56 days
World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: 56 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. For the proposed work final de-identified data from this project will be shared as widely as possible with the scientific community using UCSF DataShare (aka Dash). This self-service tool, available to any UCSF affiliated researcher, is a collaboration between University of California San Francisco's Library, and the UC Curation Center (UC3) at the California Digital Library and the UCSF Clinical and Translational Science Institute (CTSI).
Related trials for PTSD
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas C. Neylan, MD principal investigator
San Francisco VA Medical Center, San Francisco, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CORT108297 in people with PTSD, run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale for DSM-5 (CAPS) (time frame: 56 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.