Major Depressive Episode · Observational Study

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

ClinicalTrials.gov · August 12, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registry record for an ongoing observational cohort study recruiting patients with major depressive episode to identify sleep and circadian biomarkers and depressive subgroups. No results have been reported in this registry entry, and the study remains actively recruiting.

What was studied

Observational. Major Depressive Episode. n = 1,000. 1 site: France.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an ongoing observational cohort registry record with no reported results; it describes a planned study designed to identify biomarkers in depression via sleep and circadian measures.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measure: amount of REM sleep (assessed at at inclusion)

DesignObservational

PopulationMajor Depressive Episode

Sample size1,000

Setting1 site: France

Reported figures

Quoted from the source exactly as published.

Planned enrollment1000

Primary outcome measureamount of REM sleep, at inclusion

Study typeObservational

Caveats

This is a registry record only; no results are reported and the study is still recruiting.
No details provided on study methods, measurement protocols, or planned analyses.
No secondary outcomes, follow-up duration, or completion date specified in the registry entry.
Biomarker identification is exploratory; clinical utility of findings cannot be assessed at this stage.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational cohort design; no randomization or control group specified.

Directness

moderate

Aims to identify biomarkers and subgroups in major depressive episode; clinical relevance stated.

Consistency

insufficient

Registry record; no results reported; consistency cannot be assessed.

Risk of bias

insufficient

Registry record; no methods detail on blinding, measurement, or analysis protocol provided.

Sample adequacy

moderate

Estimated enrollment 1000 participants; adequate for exploratory biomarker work.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05866991). This is a study registration, not published results. Lead sponsor: Assistance Publique - Hôpitaux de Paris. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1000 participants (ESTIMATED). Conditions: Major Depressive Episode. Primary outcome measures: amount of REM sleep , at inclusion. Brief 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 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT05866991Major Depressive EpisodeAssistance Publique - Hôpitaux de Paris