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Clinical Trials/NCT06036160
NCT06036160
Not yet recruiting
Not Applicable

Evaluation de Soins Primaires Intégrés en Psychiatrie

Association De La Msp Pasteur0 sites50 target enrollmentNovember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depressive Disorder
Sponsor
Association De La Msp Pasteur
Enrollment
50
Primary Endpoint
Percentage of patients completing the study per-protocol
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2024
End Date
November 1, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Association De La Msp Pasteur
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Percentage of patients completing the study per-protocol

Time Frame: 3 years

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