Back to resultsFeasibility of Integrated Care of Depression in Primary Care Pathways (ESPRI-PSY)
Primary Purpose
Depressive Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Integrated care
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Integrated care
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients completing the study per-protocol
Secondary Outcome Measures
Full Information
NCT ID
NCT06036160
First Posted
September 5, 2023
Last Updated
September 12, 2023
Sponsor
Association De La Msp Pasteur
1. Study Identification
Unique Protocol Identification Number
NCT06036160
Brief Title
Feasibility of Integrated Care of Depression in Primary Care Pathways
Acronym
ESPRI-PSY
Official Title
Evaluation de Soins Primaires Intégrés en Psychiatrie
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
November 1, 2026 (Anticipated)
Study Completion Date
November 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association De La Msp Pasteur
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrated care
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Integrated care
Intervention Description
Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation
Primary Outcome Measure Information:
Title
Percentage of patients completing the study per-protocol
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Feasibility of Integrated Care of Depression in Primary Care Pathways
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