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NCT06036160 Clinical Trial

Feasibility of Integrated Care of Depression in Primary Care Pathways

Depressive Disorder Clinical Trial

— ESPRI-PSY  

Official title:
Evaluation de Soins Primaires Intégrés en Psychiatrie

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06036160
Other study ID # 202201
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 1, 2024
Est. completion date November 1, 2026

Study information
Verified date January 2024
Source Association De La Msp Pasteur
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This protocol is a feasibility study of an integrated primary care pathway for patients suffering from difficult-to-treat depression. 50 patients will be recruited and followed for two years.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date November 1, 2026
Est. primary completion date November 1, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - age 18-65 years - Good understanding of french language - Major depressive disorder based on DSM-V criteria - MADRS > 19 - FAilure of two antidepressants during 6wks at standard minimal dose Exclusion Criteria: - Pregnancy or lactating - People under tutelage - bipolar disorder - no health insurance - neurological disorders - contra-indication to physical activity - high suicidal risk - first degree history of bipolar disorder, schizophrenia, autism spectrum disorder

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Integrated care
Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Association De La Msp Pasteur

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of patients completing the study per-protocol 3 years
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