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NCT Number: NCT06036160

Feasibility of Integrated Care of Depression in Primary Care Pathways

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Integrated care

Other

Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation

Primary outcomes

  1. Percentage of patients completing the study per-protocol

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Association De La Msp Pasteur

Other

Registry information

Official study title

Evaluation de Soins Primaires Intégrés en Psychiatrie

Acronym: ESPRI-PSY

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 13, 2023
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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