Actively Recruiting

All Genders
ID05866991

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-05-16

1000

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying patients experiencing a major depressive episode to better understand sleep and biological rhythm markers linked to depression. This observational study is part of a French national cohort aiming to identify more uniform patient subgroups and clarify the characteristics and causes of depressive disorders, which affect up to 20% of people and have a significant impact on quality of life and health care. Despite efforts, no biomarkers have yet been adopted in clinical practice for diagnosis or treatment prediction. The study involves detailed evaluations of sleep and circadian rhythm disturbances in patients with depression, as these abnormalities are common and may influence relapse and overall functioning. Researchers assess a range of sleep characteristics, including REM sleep, slow-wave sleep stages, sleep efficiency, and movement during sleep, alongside urinary hormone levels and apnea indices. These assessments aim to better characterize depression subtypes and support more personalized psychiatric care. Participants undergo comprehensive psychiatric, addiction, sleep, and chronobiology assessments at inclusion. Measurements include polysomnography and actigraphy to assess sleep stages and quality, as well as biological samples to monitor hormonal markers. The main outcome measured is the amount of REM sleep. This observational study helps to identify markers linked to depression and supports future screening and treatment strategies, with participation duration varying by individual.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals with a depressive episode diagnosed according to DSM-5 criteria, regardless of associated characteristics and comorbidities
  • Adults and children
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • Unable to understand or read French
  • Medical condition that prevents completing questionnaires
  • Unable to give informed consent (e.g., emergency condition)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At inclusion

Participants undergo detailed evaluations of sleep, circadian rhythms, and psychiatric status to characterize depressive disorders and related biomarkers.

1 in-person assessment visit

Long-term Monitoring

Duration - Up to 10 years

Participants are observed over time to track the evolution of depressive disorders and related sleep and rhythm abnormalities for research purposes.

Periodic visits as scheduled by study centers

Trial Site Locations

Total: 1 location

1

Hôpital Bichat Claude Bernard

Paris, France, 75018

Actively Recruiting

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Research Team

P

Pierre Alexis GEOFFROY, PU-PH

J

Julia MARUANI

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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