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

NCT05866991 | Recruiting

• 1 other identifier: APHP211614
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Episode

Keywords

Depression; Biomarkers; Depressive; Disorder; Sleep; circadian rhythms; seasonal affective disorder

Outcome Measures

Primary Outcomes (1)

• amount of REM sleep

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

  at inclusion

Secondary Outcomes (25)

• duration of the first stage of REM sleep

  at inclusion

• duration of the first episode of N3

  at inclusion

• latency of the first episode of N3

  at inclusion

• duration of N1 slow-wave sleep

  at inclusion

• duration of N2 slow-wave sleep

  at inclusion

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hôpital Bichat Claude Bernard

Paris, 75018, France

RECRUITING

MeSH Terms

Conditions

Depression; Disease; Seasonal Affective Disorder

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Depressive Disorder; Mood Disorders; Mental Disorders

Central Study Contacts

Pierre Alexis GEOFFROY, PU-PH

CONTACT

01 40 25 82 62; Pierrealexis.geoffroy@aphp.fr

Julia MARUANI

CONTACT

julia.maruani@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: May 19, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): May 1, 2033
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

FR (1)