Not yet recruiting NCT06036160

Feasibility of Integrated Care of Depression in Primary Care Pathways

No phase Interventional Depressive Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Integrated care.
Who it may be relevant to: Registry conditions: Depressive Disorder. Basic parameters: 18 years — 65 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Evaluation de Soins Primaires Intégrés en Psychiatrie

Overview

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.

Interventions

Other Integrated care
Psychiatric follow-up, cognitive behavioral therapy, physical exercise, psychoeducation

Primary outcome measures

Percentage of patients completing the study per-protocol [Time frame: 3 years]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: N/A
Model: Single group
Masking: Open label
Primary purpose: Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06036160 · 202201

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗