PRADESH: Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization.

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05678907

Collaborator

(none)

150

Enrollment

Location

11.9

Anticipated Duration (Months)

12.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational

Anticipated Enrollment :

150 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Predictive Value of the DD4 Questionnaire on Depressive Relapse After Hospitalization.

Anticipated Study Start Date :

Jan 2, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Outcome Measures

Primary Outcome Measures

Depressive episode relapse [Month 3]
Relapse within three months of hospitalization

Secondary Outcome Measures

Psychic symptoms of depression [Month 3]
The Ducher DD4 scale is presented in the form of four modules that assess the same questionnaire in different ways. The questionnaire consists of 15 items evaluating the psychic symptoms of depression (somatic criteria were not retained in order to allow the use of this instrument in patients with an associated physical pathology.
Evaluation of depressive symptomology [Month 3]
Measured with the Montgomery and Asberg (MADRS) scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique de l'Auzon	La Roche-Blanche		France	63670

Sponsors and Collaborators

GCS Ramsay Santé pour l'Enseignement et la Recherche

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

GCS Ramsay Santé pour l'Enseignement et la Recherche

ClinicalTrials.gov Identifier:

NCT05678907

Other Study ID Numbers:

COS-RGDS-2022-06-054

First Posted:

Jan 10, 2023

Last Update Posted:

Jan 10, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Recurrence

Study Results

No Results Posted as of Jan 10, 2023