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SEVENNCT04452500

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

StatusCompleted
PhasePhase 2
Primary completion
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Record History

All 13 versions: 13 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 6 more changesShow less
    • Primary completion date changed from estimate of Dec 31, 2026 to Jul 31, 2026
    • Enrollment target: estimated 40 to confirmed 39
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Site details revised at 2 of 2 sites
    • Study description expanded, about 1 word
  2. Enrollment target: 88 to 40
    • Primary and study completion dates: Dec 31, 2025 to Dec 31, 2026
    v12
  3. Primary and study completion dates: Dec 31, 2024 to Dec 31, 2025v11
  4. Eligibility criteria shortened, about 106 words
    • Study description shortened, about 152 words
    • Study title expanded, about 2 words
    v10
  5. Site details revised at 1 of 2 sites
    • Eligibility criteria shortened, about 2 words
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v8
  2. Start date: Sep 1, 2022 to Oct 15, 2022v7
  3. Start date: Jun 15, 2022 to Sep 1, 2022v6
  4. Start date: Apr 1, 2022 to Jun 15, 2022v5
  5. Start date: Jan 3, 2022 to Apr 1, 2022
    • Site contact updated
    v4
  6. Primary and study completion dates: Dec 29, 2023 to Dec 31, 2024
    • Start date: Sep 1, 2021 to Jan 3, 2022
    v3
  7. Primary and study completion dates: Mar 17, 2023 to Dec 29, 2023
    • Start date: Jan 1, 2021 to Sep 1, 2021
    • Study sites: 2 to 1
    • Collaborators shortened, about 7 words
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Clinician Administered PTSD Scale for DSM-5 (CAPS)
Timeframe: 56 days
Frequency, Intensity, Burden of Side Effects (FIBSER)
Timeframe: 56 days

Secondary (3)

Columbia Suicide Severity Rating Scale
PTSD Checklist for DSM-5
World Health Organization Quality of Life (WHOQOL-BREF)

Arms and interventions

CORT108297Experimental

CORT108297- 180 milligrams (mg) daily for 7 days

PlaceboPlacebo comparator

Placebo- 180 milligrams (mg) daily for 7 days

Drugs: CORT108297, Placebo

Sites

2 sites in 1 country