Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)
SEVEN
2 other identifiers
interventional
40
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2022
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2020
CompletedFirst Posted
Study publicly available on registry
June 30, 2020
CompletedStudy Start
First participant enrolled
October 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
January 29, 2026
January 1, 2026
4.2 years
June 26, 2020
January 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
56 days
Secondary Outcomes (3)
Columbia Suicide Severity Rating Scale
56 days
PTSD Checklist for DSM-5
56 days
World Health Organization Quality of Life (WHOQOL-BREF)
56 days
Study Arms (2)
CORT108297
EXPERIMENTALCORT108297- 180mg daily for 7 days
Placebo
PLACEBO COMPARATORPlacebo- 180mg daily for 7 days
Interventions
Eligibility Criteria
You may qualify 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.
- 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.
You may not qualify 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 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
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Tuscaloosa VA Medical Center, Tuscaloosa, AL
Tuscaloosa, Alabama, 35404, United States
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, 94121-1563, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas C. Neylan, MD
San Francisco VA Medical Center, San Francisco, CA
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2020
First Posted
June 30, 2020
Study Start
October 15, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
January 29, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- Within 1 year of the end of the funding period.
- Access Criteria
- After the raw data is made available on the Dash site, anyone will also be able to view the descriptive metadata used to index the data set. This information is publicly available to allow for maximum discoverability. Individuals wishing to access the data must agree to terms of use for the data set via a Data Use Agreement, and may have to meet additional requirements as set forth by the PI. The data will be permanently archived and available through the California Digital Library.
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).