Feasibility of Integrated Care of Depression in Primary Care Pathways (ESPRI-PSY)

August 3, 2024 updated by: Association De La Msp Pasteur

Evaluation de Soins Primaires Intégrés en Psychiatrie

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients completing the study per-protocol
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association De La Msp Pasteur

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

September 5, 2023

First Submitted That Met QC Criteria

September 12, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

August 3, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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