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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05046587
Other study ID # RECHMPL21_0395
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date September 30, 2021

Study information

Verified date November 2021
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 898
Est. completion date September 30, 2021
Est. primary completion date September 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary characterization of the patient clinical phenotype characterization of the patient clinical phenotype day 1
Secondary Suicidal events at one 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) 1 year
Secondary Hospitalization for suicidal ideation Occurrence of hospitalization for suicidal ideation, based on the patient medical record 1 year
Secondary Suicidal events at one year Occurrence of suicidal events (actual, interrupted and aborted or self-aborted suicide attempts) based on the patient medical records 1 year
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