Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization (PRADESH)

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.

Study Overview

• Status: Recruiting
• Conditions: Depressive Episode

Detailed Description

Patients in the study were hospitalized following a characterized depressive episode. The study is based on a review of these patients' medical records and data from the three-month assessment. No additional assessments are planned.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• France
  • La Roche-Blanche, France, 63670
    • Recruiting
    • Clinique de l'Auzon
    • Contact: Anne-Marie TRONCHE, MD; Phone Number: 33 04 73 79 84 46; Email: a.tronche@ramsaygds.fr
    • Contact: Jean-Luc DUCHER, MD
    • Principal Investigator: Anne-Marie TRONCHE, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depressive episode relapse	Relapse within three months of hospitalization	Month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychic symptoms of depression	The Multidimensional Self-Questionnaire for Depression Assessment DD4 (Ducher's Depression Scale) is presented in the form of four modules. Each module consists of 15 identical questions (I feel sad, I suffer morally...). The formulation of the questions allows for evaluation from 0 to 4 in different dimensions: DD4 A: Global Evaluation (not at all true, a little true, rather true, very true, completely true) DD4 F: Frequency Evaluation (never, sometimes, often, very often, permanently) DD4 I: Intensity Evaluation (not at all, slightly, fairly, a lot, enormously) DD4 M: Maximal Evaluation (uses the criteria of the global evaluation, but during the moments when the patient feels the saddest or most depressed). An additional question asks about the frequency of these periods (never, sometimes, often, very often, permanently).	Month 3
Depressive symptomology	Measured with the Montgomery and Asberg (MADRS) scale	Month 3

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: December 22, 2022
• First Submitted That Met QC Criteria: December 22, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Estimated): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 28, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Recurrence
• Other Study ID Numbers: COS-RGDS-2022-06-054

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No