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Characterization of Suicidal Depression

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05046587
Collaborator
(none)
898
Enrollment
1
Location
4
Actual Duration (Months)
225.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Antidepressants are widely used to prevent suicidal risk. However, even though the use of antidepressants has been associated with a 40-60% decrease in suicidal risk, they do not seem to be sufficient and appropriate. Indeed recent studies have shown that patients with a history of suicide attempt and/or with current suicidal ideation (SI) respond less well to antidepressant treatments. This suggests that patients with depression with SI may be different from those with depression without SI, thus requiring specific treatments for both SI reduction and depressive remission. In other words, suicidal depression may be a specific subtype of depression.

The study aims to characterize the clinical phenotype of patients with suicidal depression vs. those without suicidal depression, and to assess the occurrence of suicidal events at one year in patients with suicidal depression vs. without suicidal depression.

All data having already been collected during the particpation of patients in various clinical research studies of the department

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    898 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Characterization of Suicidal Depression Within a Large Cohort of Inpatients: a One-year Prospective Study.
    Actual Study Start Date :
    Jun 1, 2021
    Actual Primary Completion Date :
    Sep 1, 2021
    Actual Study Completion Date :
    Sep 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. characterization of the patient clinical phenotype [day 1]

      characterization of the patient clinical phenotype

    Secondary Outcome Measures

    1. Suicidal events at one year [1 year]

      Occurrence of suicidal events (actual, interrupted and aborted or self-aborted suicide attempts) assessed with C-SSRS suicidal behaviour subscale (4 yes/no questions)

    2. Hospitalization for suicidal ideation [1 year]

      Occurrence of hospitalization for suicidal ideation, based on the patient medical record

    3. Suicidal events at one year [1 year]

      Occurrence of suicidal events (actual, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Over 18 years old

    • Hospitalization in the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) between 2012 and 2019

    • Having being enrolled in one the department's clinical studies between 2012 and 2019

    • Moderate to severe characterized depressive episode according to DSM-5 diagnostic criteria (severity assessed with BDI, IDSC-30 and QIDS)

    Exclusion criteria:

    • Protection by law (guardianship or curatorship)

    • Deprivation of liberty (by judicial or administrative decision)

    • Bipolar disorder

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Bénédicte NOBILE, PharmD, PhD, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05046587
    Other Study ID Numbers:
    • RECHMPL21_0395
    First Posted:
    Sep 16, 2021
    Last Update Posted:
    Nov 15, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Suicide
    Suicidal Ideation
    Suicidal Depression
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Nov 15, 2021