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.
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.
Julia MARUANI contact
France1 site, 1 recruiting
- Recruiting
Hôpital Bichat Claude Bernard
Paris, Paris, 75018
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.
- Conditions
- Major Depressive Episode
- 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.
amount of REM sleep
during the polysomnography, amount of REM sleep (in minutes)
Measured: at inclusion
Secondary outcomes (25)
duration of the first stage of REM sleep
Measured: at inclusion
duration of the first episode of N3
Measured: at inclusion
latency of the first episode of N3
Measured: at inclusion
duration of N1 slow-wave sleep
Measured: at inclusion
duration of N2 slow-wave sleep
Measured: at inclusion
duration of N3 slow-wave sleep
Measured: at inclusion
percentage of slow-wave sleep N1
Measured: at inclusion
percentage of slow-wave sleep N2
Measured: at inclusion
percentage of slow-wave sleep N3
Measured: at inclusion
measurement of total sleep time
Measured: at inclusion
sleep efficiency
Measured: at inclusion
nocturnal awakenings
Measured: at inclusion
latency of different sleep stages
Measured: at inclusion
duration of different sleep stages
Measured: at inclusion
density of different sleep stages
Measured: at inclusion
movement during sleep
Measured: at inclusion
percentage of time total sleep spent under 90% SaO2
Measured: at inclusion
Mean for iterative latency tests falling asleep
Measured: at inclusion
urinary dosage 6-sulfatoxymelatonin over 24 hours.
Measured: at inclusion
urinary dosage cortisol over 24 hours.
Measured: at inclusion
apnea-hypopnea index
Measured: at inclusion
index of periodic leg movements
Measured: at inclusion
characterization of the chronotype
by using questionnaire MCTQ
Measured: at inclusion
characterization of the patient's psychiatric state
using questionnaires: MADRS, YMRS, QIDS-SR, MATHYS and GAD-7
Measured: at inclusion
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.
- First posted19 May 2023
- Study start1 Feb 2023
- Primary completion1 Feb 2033 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT05866991
- Acronym / sponsor ID
- SoPsy-SoSad / APHP211614
- Conditions
- Major Depressive Episode
- Keywords
- Depression, Biomarkers, Depressive, Disorder, Sleep, circadian rhythms, seasonal affective disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 1 Feb 2033 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 19 May 2023 (actual)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- don't understand or read french
- Medical condition incompatible with administration of questionnaire
- impossibility to give informed decision (subject in an emergency condition, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
amount of REM sleep
Time frame: at inclusion
during the polysomnography, amount of REM sleep (in minutes)
25 secondary outcomes
duration of the first stage of REM sleep
Time frame: at inclusion
duration of the first episode of N3
Time frame: at inclusion
latency of the first episode of N3
Time frame: at inclusion
duration of N1 slow-wave sleep
Time frame: at inclusion
duration of N2 slow-wave sleep
Time frame: at inclusion
duration of N3 slow-wave sleep
Time frame: at inclusion
percentage of slow-wave sleep N1
Time frame: at inclusion
percentage of slow-wave sleep N2
Time frame: at inclusion
percentage of slow-wave sleep N3
Time frame: at inclusion
measurement of total sleep time
Time frame: at inclusion
sleep efficiency
Time frame: at inclusion
nocturnal awakenings
Time frame: at inclusion
latency of different sleep stages
Time frame: at inclusion
duration of different sleep stages
Time frame: at inclusion
density of different sleep stages
Time frame: at inclusion
movement during sleep
Time frame: at inclusion
percentage of time total sleep spent under 90% SaO2
Time frame: at inclusion
Mean for iterative latency tests falling asleep
Time frame: at inclusion
urinary dosage 6-sulfatoxymelatonin over 24 hours.
Time frame: at inclusion
urinary dosage cortisol over 24 hours.
Time frame: at inclusion
apnea-hypopnea index
Time frame: at inclusion
index of periodic leg movements
Time frame: at inclusion
characterization of the chronotype
Time frame: at inclusion
characterization of the patient's psychiatric state
Time frame: at inclusion
Sleep onset and offset
Time frame: at inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
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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.
Julia MARUANI contact
1 site in 1 country: see every site and its status.
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.