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Major Depressive EpisodeSoPsy-SoSadNCT05866991

Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders

An observational study of Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris 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

Despite international efforts to identify biomarkers of depression, none has been transferred to clinical practice, neither for diagnosis, evolution, nor therapeutic response. This led us to build a French national cohort (through the clinical and research network named SoPsy within the French biological psychiatry… Read more about this study

Who is it for?
Any age
Conditions the study is for
Major Depressive Episode
How many people
1,000 participants
Where
1 siteFrance
Study dates
1 Feb 2023to 1 May 2033
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 Any age
  • All sexes
  • Child, Adult, Older adult

Study population: The entry point for the cohort is any patient with a major depressive episode, in order to integrate the maximum variance in terms of manifestations, and thus to be able to contrast the different clinical pictures according to the biomarkers of sleep and biological rhythms. The aim of this cohort is to pool the efforts of this network and to homogenise the assessments, in order to characterise more precisely and in a standardised manner the alterations in sleep and rhythms in depressive disorders, according to the different subtypes of disorder.

Who may be able to join

  • Individuals with depressive episode characterized according to the DSM-5 criteria regardless of the associated characteristics and comorbidities.
  • Adult and child
  • Affiliated to a social security

Who cannot join

  • don't understand or read french
  • Medical condition incompatible with administration of questionnaire
  • impossibility to give informed decision (subject in an emergency condition, etc.)

Trial locations and contacts

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

Pierre Alexis GEOFFROY, PU-PH contact

01 40 25 82 62 ext. +33

Pierrealexis.geoffroy@aphp.fr

Julia MARUANI contact

julia.maruani@aphp.fr

France1 site, 1 recruiting
  • Hôpital Bichat Claude Bernard

    Paris, Paris, 75018

    Recruiting

Other trials in France

About this study

Despite international efforts to identify biomarkers of depression, none has been transferred to clinical practice, neither for diagnosis, evolution, nor therapeutic response. This led us to build a French national cohort (through the clinical and research network named SoPsy within the French biological psychiatry society (AFPBN) and sleep society (SFRMS)), to better identify markers of sleep and biological rhythms and validate more homogeneous subgroups of patients, but also to specify the manifestations and pathogeneses of depressive disorders.

Read the detailed description

Depressive disorders are a group of frequent and severe disorders that affect up to 20% of the general population. The WHO projects that depression will be the leading cause of disability by 2030. This growing public health problem is marked by a decrease in psychosocial functioning and quality of life, and is associated with a high rate of suicide. In addition, there is a significant economic impact including loss of productivity and a significant increase in the use of health care services. To date, the diagnosis of a depressive episode is based solely on clinical assessment and diagnostic criteria. Despite international efforts to identify biomarkers of depression, none of these identified biomarkers have been transferred to clinical practice, either for diagnosis, outcome or treatment prediction. Some of the difficulties and lack of replication of certain results are directly related to the nature of depressive disorders, which include a large number of very heterogeneous entities.

Among the markers of interest in patients with a major depressive episode (MDE), the scientific literature has shown close links between depression and disturbances in sleep and biological rhythms. Thus, more than 90% of patients suffering from MDE have sleep complaints (PMID:28972930). Moreover, it is now well demonstrated, via epidemiological and longitudinal follow-up studies, that sleep disorders, and in particular insomnia, are both risk factors and prodromes of MDE. These sleep and rhythm abnormalities seem to persist during remission phases and appear to be risk factors for depressive recurrence. Objective abnormalities, assessed by actigraphy and polysomnography, have also been demonstrated during episodes and in subjects at risk of depression, and thus appear to be both state and trait markers of the disorder. These sleep and circadian rhythm abnormalities, in addition to being associated with depressive relapse, are associated with poor global functioning, poor quality of life and risk of metabolic syndrome.

Moreover, depressive disorders encompass a very heterogeneous set of conditions, and these biomarkers seem to hold great promise for better characterising the different subtypes of disorders and for better characterising patient populations. Finally, these clinical observations make sleep and circadian rhythm abnormalities essential therapeutic targets, making it possible to propose a truly more personalised medicine in psychiatry

It is therefore urgent to better characterise the different subtypes of depressive disorders and to better understand the pathogenesis and evolution of these disorders in order to have predictive markers for conversion, recurrence or therapeutic responses. The objective of identifying such markers would also ultimately be to better screen patients and to propose adapted and personalised therapeutic strategies. The constitution of a national cohort, with a fine and homogeneous characterisation between the centres, is intended to meet these objectives by assessing psychiatry, addiction, sleep and chronobiology dimensions of depressive disorders.

Keywords
Depression, Biomarkers, Depressive, Disorder, Sleep, circadian rhythms, seasonal affective disorder
Medical subject headings
Depression, Disease, Seasonal Affective Disorder

What is being measured

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

  1. amount of REM sleep

    during the polysomnography, amount of REM sleep (in minutes)

    Measured: at inclusion

Secondary outcomes (25)
  1. duration of the first stage of REM sleep

    Measured: at inclusion

  2. duration of the first episode of N3

    Measured: at inclusion

  3. latency of the first episode of N3

    Measured: at inclusion

  4. duration of N1 slow-wave sleep

    Measured: at inclusion

  5. duration of N2 slow-wave sleep

    Measured: at inclusion

  6. duration of N3 slow-wave sleep

    Measured: at inclusion

  7. percentage of slow-wave sleep N1

    Measured: at inclusion

  8. percentage of slow-wave sleep N2

    Measured: at inclusion

  9. percentage of slow-wave sleep N3

    Measured: at inclusion

  10. measurement of total sleep time

    Measured: at inclusion

  11. sleep efficiency

    Measured: at inclusion

  12. nocturnal awakenings

    Measured: at inclusion

  13. latency of different sleep stages

    Measured: at inclusion

  14. duration of different sleep stages

    Measured: at inclusion

  15. density of different sleep stages

    Measured: at inclusion

  16. movement during sleep

    Measured: at inclusion

  17. percentage of time total sleep spent under 90% SaO2

    Measured: at inclusion

  18. Mean for iterative latency tests falling asleep

    Measured: at inclusion

  19. urinary dosage 6-sulfatoxymelatonin over 24 hours.

    Measured: at inclusion

  20. urinary dosage cortisol over 24 hours.

    Measured: at inclusion

  21. apnea-hypopnea index

    Measured: at inclusion

  22. index of periodic leg movements

    Measured: at inclusion

  23. characterization of the chronotype

    by using questionnaire MCTQ

    Measured: at inclusion

  24. characterization of the patient's psychiatric state

    using questionnaires: MADRS, YMRS, QIDS-SR, MATHYS and GAD-7

    Measured: at inclusion

  25. Sleep onset and offset

    assessed with activity with actigraphy

    Measured: at inclusion

Timeline

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

  1. First posted19 May 2023
  2. Study start1 Feb 2023
  3. Primary completion1 Feb 2033 (estimated)
  4. Study completion1 May 2033 (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
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05866991
Sponsor's protocol ID
APHP211614
Acronym
SoPsy-SoSad
Status last verified
Jul 2026
First submitted
12 Jan 2023
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Major Depressive Episode, run by Assistance Publique - Hôpitaux de Paris 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 3 inclusion and 3 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 12 Aug 2026. 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 Pierre Alexis GEOFFROY, PU-PH (01 40 25 82 62 ext. +33, Pierrealexis.geoffroy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

amount of REM sleep (time frame: at inclusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Aug 2026.

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