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

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
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
NCT ID
NCT06095310
First Posted
July 19, 2023
Last Updated
October 18, 2023
Sponsor
University Hospital, Lille
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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