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

Primary Purpose

Depression

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
New computer vision methods
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Depression focused on measuring Psychiatry, prediction, depression, objective psychiatry, personalized treatments, evolution and prognosis, computer science, artificial intelligence, innovation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Homogeneous groups

    Arm Description

    Outcomes

    Primary Outcome Measures

    Severity of depression and clinical characteristics.
    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

    Objective markers of remission of depressive episode
    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).

    Full Information

    First Posted
    July 19, 2023
    Last Updated
    October 18, 2023
    Sponsor
    University Hospital, Lille
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06095310
    Brief Title
    Clinical and Objective Psychiatric Analyses in Severe Depression.
    Acronym
    CALYPSO
    Official Title
    Evaluation of New Computer Vision Methods to Characterize Depression Severity in Patients Hospitalized for Severe Depression.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    November 2027 (Anticipated)
    Study Completion Date
    November 2027 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Lille

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Depression
    Keywords
    Psychiatry, prediction, depression, objective psychiatry, personalized treatments, evolution and prognosis, computer science, artificial intelligence, innovation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    300 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Homogeneous groups
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    New computer vision methods
    Intervention Description
    Clinical interview: Hamilton scale using multi-modal sensors (cameras, audio, bracelet, fNIRS)
    Primary Outcome Measure Information:
    Title
    Severity of depression and clinical characteristics.
    Description
    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).
    Time Frame
    The primary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge.
    Secondary Outcome Measure Information:
    Title
    Objective markers of remission of depressive episode
    Description
    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).
    Time Frame
    The secondary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical and Objective Psychiatric Analyses in Severe Depression.

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