Cohort of Patients Suffering From Major Depressive Episode With Evaluation of Sleep, Circadian Rhythms and Psychiatric Disorders (SoPsy-SoSad)

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.

Study Overview

• Status: Recruiting
• Conditions: Major Depressive Episode

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 Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Pierre Alexis GEOFFROY, PU-PH; Phone Number: +33 01 40 25 82 62; Email: Pierrealexis.geoffroy@aphp.fr
• Study Contact Backup: Name: Julia MARUANI; Email: julia.maruani@aphp.fr

Study Locations

• France
  • Paris, France, 75018
    • Recruiting
    • Hopital Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of REM sleep	during the polysomnography, amount of REM sleep (in minutes)	at inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
duration of N3 slow-wave sleep		at inclusion
percentage of slow-wave sleep N1		at inclusion
percentage of slow-wave sleep N2		at inclusion
percentage of slow-wave sleep N3		at inclusion
measurement of total sleep time		at inclusion
sleep efficiency		at inclusion
nocturnal awakenings		at inclusion
latency of different sleep stages		at inclusion
duration of different sleep stages		at inclusion
density of different sleep stages		at inclusion
movement during sleep		at inclusion
percentage of time total sleep spent under 90% SaO2		at inclusion
Mean for iterative latency tests falling asleep		at inclusion
urinary dosage 6-sulfatoxymelatonin over 24 hours.		at inclusion
urinary dosage cortisol over 24 hours.		at inclusion
apnea-hypopnea index		at inclusion
index of periodic leg movements		at inclusion
characterization of the chronotype	by using questionnaire MCTQ	at inclusion
characterization of the patient's psychiatric state	using questionnaires: MADRS, YMRS, QIDS-SR, MATHYS and GAD-7	at inclusion
Sleep onset and offset	assessed with activity with actigraphy	at inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): February 1, 2033
• Study Completion (Anticipated): May 1, 2033

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Sleep; Biomarkers; Disorder; circadian rhythms; seasonal affective disorder; Depressive
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mood Disorders; Depression; Depressive Disorder; Problem Behavior; Mental Disorders; Depressive Disorder, Major
• Other Study ID Numbers: APHP211614

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No