NCT06036160

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
5mo left

Started Nov 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Nov 2024Nov 2026

First Submitted

Initial submission to the registry

September 5, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

September 5, 2023

Last Update Submit

August 3, 2024

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients completing the study per-protocol

    3 years

Study Arms (1)

Integrated care

EXPERIMENTAL
Other: Integrated care

Interventions

Integrated careOTHER

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

Integrated care

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Mood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Delivery of Health CarePatient Care ManagementHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 13, 2023

Study Start

November 1, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share