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Clinical and Objective Psychiatric Analyses in Severe Depression. (CALYPSO)

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ClinicalTrials.gov Identifier: NCT06095310
Recruitment Status : Not yet recruiting
First Posted : October 23, 2023
Last Update Posted : October 23, 2023
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Study Description
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Brief Summary:

Participation in the CALYPSO project will be offered to all patients with severe depression hospitalized in the adult psychiatry department of Lille CHU.

An initial visit will provide a standardized clinical assessment with: a medical history and history of the disease, a standardized structured Hamilton scale interview (scale with a score from 0 to 21; the higher the score, the more severe the depression) to assess the severity of depression, and a search for the different features of severe depression (melancholic, psychotic, anxious, catatonic, seasonal) using DSM-5 criteria (list of criteria to be validated to determine the type of clinical features). When assessing the severity of depression using the Hamilton scale interview, the patient will be seated in an armchair 2 to 3 meters from a camera on a tripod, positioned behind the clinician and enabling the entire interview to be recorded and, in particular, several observable and measurable psychiatric signs and symptoms, known as objective markers. From the video will be extracted face landmark and pose parameter using state-of-the-art open source software (Mediapipe) to analyze patients' emotional facial expressions and spatial movements. Moreover, a microphone will be used to capture the audio synchronously with the video. Speech will be automatically transcoded using state-of-the-art Automatic Speech Recognition system (DeepSpeech) to enable analysis of voice-related parameters (voice timbre, prosody, sound intensity). A recording of physical activity (3-axis accelerometer sensor; 32 Hz) and emotional reactivity (heart rate in beats per minute 1Hz; electrodermal activity 4 Hz; skin temperature in degrees 4 Hz; Empatica© bracelet) and brain activity (cerebral blood flow change index 10Hz; pulse rate in bpm 10Hz; 3-axis acceleration and angular velocity of the head 10Hz via functional Near-Infrared Spectroscopy (fNIRS) using a HOT-2000 wearable headset) will also be offered to the patient to complete the assessment. The Hamilton scale interview and recording of objective markers will be carried out weekly during the patient's hospitalization in an examination room specifically equipped for the project, on the second floor of the Fontan Hospital, in the psychiatry department of the Lille University hospital.

Longitudinal follow-up will be carried out with assessments at 3, 6 and 12 months after hospital discharge, including the Hamilton scale interview and recording of objective markers (i.e., emotional facial expressions, spatial movements, voice timbre, prosody, sound intensity, physical activity, heart rate, electrodermal activity, skin temperature).


Condition or disease Intervention/treatment Phase
Depression Behavioral: New computer vision methods Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of New Computer Vision Methods to Characterize Depression Severity in Patients Hospitalized for Severe Depression.
Estimated Study Start Date : November 2023
Estimated Primary Completion Date : November 2027
Estimated Study Completion Date : November 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Homogeneous groups Behavioral: New computer vision methods
Clinical interview: Hamilton scale using multi-modal sensors (cameras, audio, bracelet, fNIRS)


Outcome Measures
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Primary Outcome Measures :
  1. Severity of depression and clinical characteristics. [ Time Frame: The primary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge. ]
    The severity of depression will be assessed with the interview on the Hamilton scale (a scale with a score from 0 to 21; the higher the score, the more severe the depression), and clinical features will be determined according to DSM-5 criteria (list of criteria to be validated to determine the type of clinical features).


Secondary Outcome Measures :
  1. Objective markers of remission of depressive episode [ Time Frame: The secondary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge. ]
    The interviews will be filmed and recorded in order to collect objective markers of depression (i.e., emotional facial expressions, spatial movements, voice timbre, prosody, sound intensity, physical activity, heart rate, electrodermal activity, skin temperature).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, over 18 years of age
  • with severe depression as defined by DSM-5 criteria hospitalized in the adult psychiatry department of Lille University Hospital.
  • Socially insured
  • Patient willing to comply with all study procedures and duration.

Exclusion Criteria:

  • Refusal to participate after receiving clear and fair information about the study
  • Pregnant or breast-feeding women
  • Person deprived of liberty or under guardianship or curatorship
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT06095310    
Other Study ID Numbers: 2021-0366
2022-A01160-43 ( Other Identifier: ID-RCB number, ANSM )
First Posted: October 23, 2023    Key Record Dates
Last Update Posted: October 23, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Lille:
Psychiatry
prediction
depression
objective psychiatry
personalized treatments
 evolution and prognosis
computer science
artificial intelligence
innovation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders