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NCT05678907 Clinical Trial

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

Depressive Episode Clinical Trial

— PRADESH  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05678907
Other study ID # COS-RGDS-2022-06-054
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date January 2, 2023
Est. completion date December 31, 2023

Study information
Verified date December 2022
Source GCS Ramsay Santé pour l'Enseignement et la Recherche
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 150
Est. completion date December 31, 2023
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Clinique de l'Auzon La Roche-Blanche

Sponsors (1)
Lead Sponsor Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Depressive episode relapse Relapse within three months of hospitalization Month 3
Secondary Psychic symptoms of depression 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.		 Month 3
Secondary Evaluation of depressive symptomology Measured with the Montgomery and Asberg (MADRS) scale Month 3
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