NCT02414711

Brief Summary

Depression has emotional consequences, social and important business. Reaching at least 7.5% of French aged 15 to 85 years. General Practitioners are the first professional consulted in terms of frequency of consultations. Indeed, in primary care, 10 to 25% of patients with depression that General Practitioners are often alone to support and follow. But General Practitioners are faced with diagnostic difficulties facing the diagnosis of depression, because if the patient does not engage itself, no tool is validated in France to help them in their diagnosis. However, standardized questionary exist that allow to overcome this difficulty. Questionary used in other european countries. Among them, the HSCL25 scale was selected by a systematic review of literature and a RAND UCLA type of consensus procedure. This HSCL25 scale is the most efficient for the diagnosis of depression in terms of efficiency tool, reproducibility and ergonomics. However, it remains necessary to confirm its validity in terms of the French translation and in terms of efficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,128

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 19, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

April 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

December 3, 2025

Status Verified

January 1, 2017

Enrollment Period

8 months

First QC Date

March 19, 2015

Last Update Submit

November 26, 2025

Conditions

Keywords

DepressionPrimary careGeneral Practitioners

Outcome Measures

Primary Outcomes (2)

  • To validate the French translation of the HSCL25 scale

    The score between HSCL25 scale and PSE9 questionary will be compared

    1 month

  • To assess the HSCL25 scale diagnosis efficacy of depression in primary care ambulatory practice

    The score between HSCL25 scale and PSE9 questionary will be compared

    1 month

Study Arms (2)

No depressed

OTHER

If the result of the HSCL25 scale is inferior than 1.75, then the patient is considered as no depressed. 50 of these patients have to have a psychological interview with the PSE9 questionary to validate the result of the HSCL25 scale.

Other: HSCL25 scaleOther: PSE9 questionary

Depressed

OTHER

If the result of the HSCL25 scale is superior or equal to 1.75, then the patient is considered as depressed. 50 of these patients have to have a psychological interview with the PSE9 questionary to validate the result of the HSCL25 scale.

Other: HSCL25 scaleOther: PSE9 questionary

Interventions

The patient must answer to 25 questions of the HSCL25 scale. In function of the results, the patients was diagnosed depressed (≥1.75) or not depressed (\<1.75)

DepressedNo depressed

On the 900 patients recruited, 50 patients who was diagnosed depressed or no depressed have to have a psychological interview with the PSE9 questionary to validate the first diagnosis done by the HSCL25 scale

DepressedNo depressed

Eligibility Criteria

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

You may qualify if:

  • Adult (18 and over) consultant in primary care

You may not qualify if:

  • Child or young person under 18
  • Women with a declared pregnancy to prevent puerperal depression whose support is different.
  • Adult consultant to obtain a medical certificate
  • Psychotic patients and\\or requiring immediate care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cabinet médical en zone urbaine

Brest, France, 29200, France

Location

Cabinet médical en zone rurale - Pôle Santé Universitaire

Lanmeur, France, 29620, France

Location

Cabinet médical en zone semi-rurale

Plounéour-Trez, France, 29890, France

Location

Related Publications (1)

  • Nabbe P, Le Reste JY, Guillou-Landreat M, Gatineau F, Le Floch B, Montier T, Van Marwijk H, Van Royen P. The French version of the HSCL-25 has now been validated for use in primary care. PLoS One. 2019 Apr 4;14(4):e0214804. doi: 10.1371/journal.pone.0214804. eCollection 2019.

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Patrice NABBE, GP

    GP department

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 13, 2015

Study Start

June 1, 2015

Primary Completion

February 1, 2016

Study Completion

October 1, 2016

Last Updated

December 3, 2025

Record last verified: 2017-01

Locations