NCT05678907

Brief Summary

This is a prospective, longitudinal, single-center observational study of data from the medical records of patients hospitalized after a characterized depressive episode and reviewed three months after hospital discharge, as part of a normally scheduled evaluation.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 22, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

January 2, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

December 22, 2022

Last Update Submit

June 28, 2024

Conditions

Depressive Episode

Outcome Measures

Primary Outcomes (1)

  • Depressive episode relapse

    Relapse within three months of hospitalization

    Month 3

Secondary Outcomes (2)

  • Psychic symptoms of depression

    Month 3

  • Depressive symptomology

    Month 3

Eligibility Criteria

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

Patients hospitalized for a characterized depressive episode and considered in remission at discharge.

You may qualify if:

  • Patient 18 years of age or older, having been informed of the research
  • Patient hospitalized at the Auzon Clinic for a characterized depressive episodé (isolated episode or recurrent depressive disorder)
  • Discharged from hospitalization
  • Considered in remission (total or partial) and with a MADRS score \< 20

You may not qualify if:

  • Patient hospitalized for \< 15 days
  • Patient with bipolar depression
  • Patient with a psychotic disorder
  • Patient using narcotics with a "moderate to severe" severity
  • Patient previously included in this study
  • Patient under court protection, guardianship or curatorship
  • Patient unablé to respond correctly to a depression self-assessment questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique de l'Auzon

La Roche-Blanche, 63670, France

RECRUITING

Study Design

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

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 10, 2023

Study Start

January 2, 2023

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

July 1, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)