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PRECLIPNCT05358067

Predictability of the Clinical Global Impression Scale (CGI) in Post Immediate in Psychotraumatic Impact

StatusTerminated
PhaseNot specified
Primary completion
Track this trial

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Record History

All 6 versions: 6 with changes below. See every version on ClinicalTrials.gov ↗

  1. Trial terminated Sponsor's reason: Inclusion period completed, target number of patients not reached Show 8 more changesShow less
    • Final enrollment: 79 participants (planned 241)
    • Primary completion date changed from estimate of Oct 23, 2026 to Jul 22, 2024
    • Study sites: 5 to 4
    • Study completion date changed from estimate of Apr 23, 2027 to Jan 30, 2025
    • Eligibility criteria expanded, about 6 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Publications: details revised at 4 of 5 entries
    • Study description expanded, about 2 words
  2. Primary completion date: Nov 24, 2026 to Oct 23, 2026
    • Study completion date: Apr 24, 2027 to Apr 23, 2027
    v5
  3. Site details revised at 2 of 5 sitesv4
  4. Primary completion date: Nov 24, 2025 to Nov 24, 2026
    • Study sites: 4 to 5
    • Study completion date: Apr 24, 2026 to Apr 24, 2027
    v3
  5. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Apr 30, 2025 to Nov 24, 2025
    • Start date changed from estimate of May 1, 2022 to Oct 24, 2022
    • Study completion date: Aug 31, 2025 to Apr 24, 2026
    • Site details revised at 4 of 4 sites
  6. Study First Submitted
  • Stopped: terminated, suspended or withdrawn
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Psychometric properties of the CGI as a predictor of occurrence of post-traumatic stress disorder
Timeframe: inclusion

Secondary (9)

Correlation between CGI score and Peritraumatic Distress Inventory scale score (PDI)
Correlation coefficient between CGI score and PCL 5 score at 1 month.
Correlation coefficient between CGI score and PCL 5 score at 6 months.
Presence/absence of a major depressive episode at 1 month in connection with traumatic event
Presence/absence of a major depressive episode at 6 months in connection with traumatic event
Show 4 moreShow less
Presence/absence of a consumption of alcohol at 1 month in connection with traumatic event
Presence/absence of a consumption of alcohol at 6 months in connection with traumatic event
Presence/absence of a consumption of substances (except alcohol) at 1 month in connection with traumatic event
Presence/absence of a consumption of substances (except alcohol) 6 months in connection with traumatic event

Sites

4 sites in 1 country