NCT05046587

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
898

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

November 15, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

July 5, 2021

Last Update Submit

November 12, 2021

Conditions

Keywords

SuicideSuicidal IdeationSuicidal Depression

Outcome Measures

Primary Outcomes (1)

  • characterization of the patient clinical phenotype

    characterization of the patient clinical phenotype

    day 1

Secondary Outcomes (3)

  • Suicidal events at one year

    1 year

  • Hospitalization for suicidal ideation

    1 year

  • Suicidal events at one year

    1 year

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Depressed patients with and without suicidal ideation, admitted to the Department of Emergency Psychiatry and Acute Care (Montpellier University Hospital) and enrolled in one of the department's clinical studies.

You may qualify if:

  • 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)

You may not qualify if:

  • Protection by law (guardianship or curatorship)
  • Deprivation of liberty (by judicial or administrative decision)
  • Bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

DepressionSuicideSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious Behavior

Study Officials

  • Bénédicte NOBILE, PharmD, PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2021

First Posted

September 16, 2021

Study Start

June 1, 2021

Primary Completion

September 1, 2021

Study Completion

September 30, 2021

Last Updated

November 15, 2021

Record last verified: 2021-11

Locations