DepressionHSCL25NCT02414711
Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care
A study testing HSCL25 scale and PSE9 questionary in people with Depression, run by University Hospital, Brest at 3 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- HSCL25 scale and PSE9 questionary
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,128 participants
- Where
- 3 sitesFrance
- Study dates
- Jun 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18 and over) consultant in primary care
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Cabinet médical en zone urbaine
Brest, France, 29200
Cabinet médical en zone rurale - Pôle Santé Universitaire
Lanmeur, France, 29620
Cabinet médical en zone semi-rurale
Plounéour-Trez, France, 29890
About this study
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.
- Conditions
- Depression
- Being tested
- HSCL25 scale, PSE9 questionary
- Keywords
- Depression, Primary care, General Practitioners
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSCL25 scaleOther
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)
PSE9 questionaryOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: HSCL25 scale; Other: 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. Receives: Other: HSCL25 scale; Other: PSE9 questionary |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate the French translation of the HSCL25 scale
The score between HSCL25 scale and PSE9 questionary will be compared
Measured: 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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrice NABBE, GP, Principal investigator, GP department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414711
- Sponsor's protocol ID
- HSCL25 Validation
- Acronym
- HSCL25
- Status last verified
- Jan 2017
- First submitted
- 19 Mar 2015
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30946774
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the French Translation of the Scale HSCL25 in the Diagnosis of Depression in Primary Care
- ClinicalTrials.gov ID
- NCT02414711
- Acronym / sponsor ID
- HSCL25 / HSCL25 Validation
- Conditions
- Depression
- Keywords
- Depression, Primary care, General Practitioners
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,128 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No depressed | Other | Other: HSCL25 scale, Other: PSE9 questionaryIf 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. |
| Depressed | Other | Other: HSCL25 scale, Other: PSE9 questionaryIf 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult (18 and over) consultant in primary care
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSCL25 scaleThe 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) | Other | Depressed, No depressed |
| PSE9 questionaryOn 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 | Other | Depressed, No depressed |
Primary outcome
To validate the French translation of the HSCL25 scale
Time frame: 1 month
The score between HSCL25 scale and PSE9 questionary will be compared
To assess the HSCL25 scale diagnosis efficacy of depression in primary care ambulatory practice
Time frame: 1 month
The score between HSCL25 scale and PSE9 questionary will be compared
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 30946774Nabbe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrice NABBE, GP principal investigator
GP department
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HSCL25 scale and PSE9 questionary in people with Depression, run by University Hospital, Brest at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To validate the French translation of the HSCL25 scale (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414711, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.