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RecruitingNCT06095310CALYPSOUpdated May 6, 2026

Clinical and Objective Psychiatric Analyses in Severe Depression.

An interventional study of New computer vision methods in Depression, sponsored by University Hospital, Lille. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University Hospital, Lille · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Nov 2023; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Depression

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Keywords

  • Psychiatry
  • prediction
  • depression
  • objective psychiatry
  • personalized treatments
  • evolution and prognosis
  • computer science
  • artificial intelligence
  • innovation
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's planned enrollment of 300 is above the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Experimental
    Homogeneous groups

    Behavioral: New computer vision methods

Interventions

  • BehavioralNew computer vision methods

    Clinical interview: Hamilton scale using multi-modal sensors (cameras, audio, bracelet, fNIRS)

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: The primary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge.

Secondary outcomes

  1. 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).

    Time frame: The secondary outcome is measured at the initial visit, then at assessments at 3, 6 and 12 months after hospital discharge.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06095310
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Oct 23, 2023
Start date
Nov 30, 2023
Primary completion
Nov 2027 (estimated)
Completion
Nov 2027 (estimated)
Last update
May 6, 2026

Study contacts

Ali AMAD, MD, PhD
Contact
ali.amad@chu-lille.fr
3 20 44 44 60 ext. +33
Ali AMAD, MD, PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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