ESPRI-PSY: Feasibility of Integrated Care of Depression in Primary Care Pathways

• Sponsor: Association De La Msp Pasteur (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06036160
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Anticipated Duration (Months): 36

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Other: Integrated care	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation de Soins Primaires Intégrés en Psychiatrie
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Nov 1, 2026
• Anticipated Study Completion Date: Nov 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Integrated care	Other: Integrated care; Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation

Outcome Measures

Primary Outcome Measures

1. Percentage of patients completing the study per-protocol [3 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Association De La Msp Pasteur

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Association De La Msp Pasteur
• ClinicalTrials.gov Identifier: NCT06036160
• Other Study ID Numbers: 202201
• First Posted: Sep 13, 2023
• Last Update Posted: Sep 13, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Depressive Disorder

Study Results

No Results Posted as of Sep 13, 2023