Phase IIa Trial of a Selective Glucocorticoid Receptor Antagonist in the Treatment of Veterans With Posttraumatic Stress Disorder (PTSD) (Seven Study)

Part of paid clinical trials in Tuscaloosa, Alabama.

Sponsor
VA Office of Research and Development
Study ID
NCT04452500
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • CORT108297 — DRUG
    CORT108297- 180mg daily for 7 days
  • Placebo — DRUG
    Placebo- 180mg daily for 7 days

Study Details

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.

Key Dates

Start date
Oct 15, 2022
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CORT108297
    CORT108297- 180mg daily for 7 days
  • Placebo Comparator: Placebo
    Placebo- 180mg daily for 7 days

Primary Outcome Measure

Clinician Administered PTSD Scale for DSM-5 (CAPS) [ Time Frame: 56 days ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tuscaloosa VA Medical Center, Tuscaloosa, ALTuscaloosaAlabama35404
Brittney Washington
[email protected]
205-554-2000
Whitney Gay
[email protected]
2055542000
San Francisco VA Medical Center, San Francisco, CASan FranciscoCalifornia94121-1563
Jennifer A Hlavin, MS
[email protected]
415-221-4810
Thomas C. Neylan, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tuscaloosa, AL

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
Tuscaloosa VA Medical Center, Tuscaloosa, AL· Tuscaloosa, ALSan Francisco VA Medical Center, San Francisco, CA· San Francisco, CA

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