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Major Depressive DisorderOSMOSENCT07305701

Cohort Study on Medical Students' Mental Health

An observational study of Major Depressive Disorder and Generalized Anxiety Disorder, run by Centre Hospitalier Régional d'Orléans at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The main objective of this study is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter the medical program (students not accepted into the second year of medical school). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Questionnaire
How many people
10,000 participants
Where
1 siteFrance
Study dates
22 Oct 2025to 31 Oct 2047
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: All students who were enrolled in their first year of health studies at the University of Orléans

Who may be able to join

  • Students who have been enrolled in first year of health studies at the University of Orléans
  • Aged 18 or over

Who cannot join

  • Does not speak French
  • Person under legal guardianship
  • Person deprived of liberty
  • Person under guardianship or trusteeship

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Centre Hospitalier Universitaire d'Orléans

    Orléans, Loiret, 45067

    Jasmina MALLET, MD-PhD, 0238229795, jasmina.mallet@chu-orleans.fr

    Jasmina MALLET, MD-PhD

    Recruiting

Other trials in France

About this study

Official title: Mental Health of Medical Students in Orleans: a Cohort Study of a New Faculty

The main objective of this study is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter the medical program (students not accepted into the second year of medical school).

Major Depressive Disorder (MDD) will be assessed using a validated tool: the Composite International Diagnostic Interview Short-Form (CIDI-SF).

Read more

This a prospective, longitudinal, cohort study. The plan is to inform each new cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study.

A link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a web page where the questionnaire can be completed. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year for the duration of the study or until the student completes their studies.

Duration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.

Read the detailed description

The COVID-19 pandemic has led to an increase in depression, particularly among younger people. The French Health Barometer, conducted every 4-5 years by Santé Publique France (SPF), found that the prevalence of a major depressive disorder (MDD) among 18-25 years old doubled (from 11.7% to 20.8%) between 2017 and 2021. There has also been an increase in suicidal thoughts and suicide attempts. Among students, data from the 2016 of observatoire de la vie étudiante (OVE) showed a higher prevalence of MDD and suicidal thoughts among students compared to the general population of the same age group. For medical students, a national study conducted in 2021 revealed rates of depression and suicidal thoughts far exceeding those of the general population of the same age. Financial difficulties were the main factor associated with the risk of depression. Indeed, students are a particularly vulnerable population to precariousness due to several factors. Economically, they often have limited income, relying on parental support, insufficient scholarships, or precarious jobs. This exposes them to difficulties in meeting essential needs such as housing, food, and healthcare. Socially, isolation can worsen their situation, especially when they move away from their family network or faced with academic pressure. Furthermore, high academic demands combined with unstable living conditions affect their mental health and may contribute to the development of psychiatric disorders, often untreated due to lack of resources or accessible care. This multidimensional precariousness highlights the need for comprehensive support for this population, especially since students rarely seek professional help. In the 2021 survey, only 32% of medical students suffering from depression received adequate care. To improve the health of medical students, it is therefore not enough to treat disorders; we must also prevent their onset by helping students achieve a state of well-being.

This a prospective, longitudinal, cohort study aims is to identify risk factors for depression among medical students by comparing them to students who completed their first year but did not enter in the medical program (students not accepted into the second year of medical school). The main objective of this study is to assess Major Depressive Disorder (MDD) using a validated tool : the Composite International Diagnostic Interview Short-Form (CIDI-SF).

We will assess the 12-month prevalence of the main psychiatric disorders evaluated, dropout using a single question, and loneliness. Care utilization will be measured, as well as care avoidance and its causes, along with financial and social insecurity, educational satisfaction, and stigma. Additional variables or questionnaires may be added through protocol amendments. These measurements will be obtained through students filling out an online questionnaire. Quantitative analyses will be conducted, starting with univariate and then multivariate models, with adjustments for known confounding factors.

The plan is to inform each cohort of students at the Orléans University Hospital medical school for 10 years. It is estimated that 5,000 to 10,000 students will be able to participate in the study.

Each year, all medical students will be informed of the protocol at meetings at the University of Orléans at the start of the academic year in September regardless of their year of study (e.g. 1st year of medical study, 2nd, 3rd, 4th year of study etc…). The study will be offered each year to students entering PASS/LAS at the Faculty of Medicine of the University of Orléans and to cohorts that have already begun their medical studies.

A link to access the study questionnaire will be sent to students by email via the registrar's office, with one email per week for four weeks. The email will contain a link to a Callyope platform where the questionnaire can be completed. Students will create an account using their university email address as their username. If the student does not object, they will have to answer the first question of the questionnaire and then complete the full online questionnaire on the Callyope platform. The questionnaire will be available online on computers or smartphones for six weeks: from mid-October to the end of November. The questionnaire will be completed each year between mid-October and the end of November for the duration of the study or until the student completes their studies.

Duration of the inclusion period: 10 years Duration of participation for each participant: maximum 12 years Total duration of the study: 22 years

As the cohort progresses, longitudinal analyses may be conducted to study the evolution of various disorders over time, adjusting for known confounding factors. Following the initial analyses of this study, a new interventional study will be set up to identify students at risk and offer them appropriate care.

Being tested
Questionnaire
Keywords
Students, Medical students, depression, epidemiology
Medical subject headings
Depressive Disorder, Major, Generalized Anxiety Disorder, Suicidal Ideation, Alcoholism, Marijuana Abuse, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Questionnaire to be completed once a year

Study groups in NCT07305701
Study groupRoleWhat they receive
Medical studentsMedical students: students who succeed to integrate medical school after the selection at the end of the first year of health studies.
Receives: Other: Questionnaire
Non medical studentsNon medical students: students who fail to integrate medical school after the selection at the end of the first year of health studies.
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measure Major Depressive Disorder prevalence

    Measure of the 12-month Major Depressive Disorder prevalence by the Composite International Diagnostic Interview Short-Form (CIDI-SF).

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Secondary outcomes (8)
  1. Measure prevalence of psychiatric disorders

    Measure the annual prevalence of psychiatric disorders other than depression (anxiety, burnout, eating disorders, alcohol and cannabis addiction, childhood trauma) among medical students by comparing them to students who completed their first year but did not enter the medical.

    Anxiety will be assessed using the GAD7; eating disorders by the SCOFF, alcohol addiction by the AUDIT, cannabis addiction by the CUDIT, burnout by the MBI-SS (student version for pre-clinical students) or the MBI-HSS (caregiver version for externs and residents), and childhood trauma by the ACE.

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  2. Identify risk and protective factors for psychiatric disorders

    Identify risk and protective factors for psychiatric disorders other than depression (anxiety, burnout, eating disorders, alcohol and cannabis addiction) among medical students by comparing them to students who completed their first year but did not enter the medical program.

    Anxiety will be assessed using the GAD7; eating disorders by the SCOFF, alcohol addiction by the AUDIT, cannabis addiction by the CUDIT, burnout by the MBI-SS (student version for pre-clinical students) or the MBI-HSS (caregiver version for externs and residents), and childhood trauma by the ACE.

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  3. Measure Major Depressive Disorder prevalence by year

    Measure the prevalence of major depressive disorder each year among medical students by comparing them to students who have completed their first year but have not entered the medical program. Major Depressive Disorder prevalence will be measure by the Composite International Diagnostic Interview Short-Form (CIDI-SF).

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  4. Measure the prevalence of healthcare use and non-use

    Measure the prevalence of healthcare use and non-use among medical students each year by comparing them to students who completed their first year but did not enter the medical program. Healthcare use will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  5. Identify risk factors for non-use of healthcare

    Identify risk factors for non-use of healthcare among medical students by comparing them to students who completed their first year but did not enter the medical program. Healthcare use will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  6. Assess the stigma associated with psychiatric disorders

    Assess the stigma associated with psychiatric disorders or the discipline of psychiatry among medical students by comparing them to students who completed their first year but did not enter the medical program. Stigma will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA).

    Assessment of childhood trauma using the Adverse Childhood Experiences scale.

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  7. Factors of financial and social insecurity

    Study the factors of financial and social insecurity (several variables) among medical students by comparing them to students who completed their first year but did not enter the medical program. Financial and social insecurity will be assessed using questions from the WHO quality of life questionnaire, the Observatoire de la Vie Etudiants questionnaires, and the Mental Ill-ness : Clinicians' Attitudes (MICA). Loneliness will be assessed using the UCLA loneliness

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

  8. Assessment of educational support

    For postgraduate students, assess their feelings about educational support.

    Measured: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2025
  2. Study start22 Oct 2025
  3. Primary completion31 Oct 2047 (estimated)
  4. Study completion31 Oct 2047 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07305701
Sponsor's protocol ID
CHUO-2025-10
Acronym
OSMOSE
Status last verified
Dec 2025
First submitted
12 Dec 2025
Last updated
31 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Husky MM, Leon C, du Roscoat E, Vasiliadis HM. Prevalence of suicidal thoughts and behaviors among young adults between 2000 and 2021: Results from six national representative surveys in France. Psychiatry Res. 2024 Mar;333:115763. doi: 10.1016/j.psychres.2024.115763. Epub 2024 Feb 1.

    PubMed 38325160
  • Frajerman A, Chevance A, Chaumette B, Morvan Y. Prevalence and factors associated with depression and suicidal ideation among French students in 2016: A national study. Psychiatry Res. 2023 Aug;326:115263. doi: 10.1016/j.psychres.2023.115263. Epub 2023 May 30.

    PubMed 37295352
  • Frajerman A, Rolland F, Hadouiri N, Haas-Jordache A, Gouy E, Mathieu L, Goulard A, Leon C, Morvan Y. Depression and suicidal thoughts in medical students and the general population: A comparison from 2 national studies. Gen Hosp Psychiatry. 2024 Sep-Oct;90:204-205. doi: 10.1016/j.genhosppsych.2024.07.002. Epub 2024 Jul 4. No abstract available.

    PubMed 38997936
  • Rolland F, Hadouiri N, Haas-Jordache A, Gouy E, Mathieu L, Goulard A, Morvan Y, Frajerman A. Mental health and working conditions among French medical students: A nationwide study. J Affect Disord. 2022 Jun 1;306:124-130. doi: 10.1016/j.jad.2022.03.001. Epub 2022 Mar 8.

    PubMed 35276314
  • Vergeron L, Morvan Y, Hadouiri N, Haas-Jordache A, Gouy E, Mathieu L, Goulard A, Rolland F, Frajerman A. Use of service and treatment adequacy in medical students and residents suffering from depression in France: A nationwide study. Psychiatry Res. 2024 Sep;339:115975. doi: 10.1016/j.psychres.2024.115975. Epub 2024 May 31.

    PubMed 38875916
  • Frajerman A. [Which interventions improve the well-being of medical students? A review of the literature]. Encephale. 2020 Feb;46(1):55-64. doi: 10.1016/j.encep.2019.09.004. Epub 2019 Nov 22. French.

    PubMed 31767254
  • Gosling CJ, Colle R, Cartigny A, Jollant F, Corruble E, Frajerman A. Measuring loneliness: a head-to-head psychometric comparison of the 3- and 20-item UCLA Loneliness Scales. Psychol Med. 2024 Oct;54(14):3821-3827. doi: 10.1017/S0033291724002083. Epub 2024 Oct 31.

    PubMed 39479755
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PubMed 16717171
  • Garcia FD, Grigioni S, Chelali S, Meyrignac G, Thibaut F, Dechelotte P. Validation of the French version of SCOFF questionnaire for screening of eating disorders among adults. World J Biol Psychiatry. 2010 Oct;11(7):888-93. doi: 10.3109/15622975.2010.483251.

    PubMed 20509759
  • Gache P, Michaud P, Landry U, Accietto C, Arfaoui S, Wenger O, Daeppen JB. The Alcohol Use Disorders Identification Test (AUDIT) as a screening tool for excessive drinking in primary care: reliability and validity of a French version. Alcohol Clin Exp Res. 2005 Nov;29(11):2001-7. doi: 10.1097/01.alc.0000187034.58955.64.

    PubMed 16340457
  • Luquiens A, Berger-Viergat A, Larrieu A, Artigaud L, Fener C, Adamson S, Laprevote V, Rolland B. Validation of the French version of the Cannabis Use Disorder Identification Test-Revised and comparison with the Cannabis Abuse Screening Test for screening cannabis use disorder in a psychiatric sample. Drug Alcohol Rev. 2021 Nov;40(7):1334-1339. doi: 10.1111/dar.13298. Epub 2021 Apr 14.

    PubMed 33855757
  • Simon N, Verdoux H. [Impact of education program and clinical posting in psychiatry on medical students' stigmatizing attitudes towards psychiatry and psychiatric disorders]. Encephale. 2018 Sep;44(4):329-336. doi: 10.1016/j.encep.2017.05.003. Epub 2017 Jun 9. French.

    PubMed 28606624

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Disorder and Generalized Anxiety Disorder, run by Centre Hospitalier Régional d'Orléans at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 31 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 1 site 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jasmina MALLET, MD-PhD (0238229795 ext. +33, jasmina.mallet@chu-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measure Major Depressive Disorder prevalence (time frame: Students fulfil the questionnaire on line once a year from enrollment until students complete their studies.). 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 NCT07305701, which also lists 12 linked publications.

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 31 Dec 2025.

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