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DepressionCALYPSONCT06095310

Clinical and Objective Psychiatric Analyses in Severe Depression.

A study testing New computer vision methods in people with Depression, run by University Hospital, Lille at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
New computer vision methods
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteFrance
Study dates
30 Nov 2023to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Hôpital Fontan 1 - CHU de Lille

    Lille, 59000

    DRI, 320444145 ext. +33, drs.promotion@chu-lille.fr

    Recruiting

Other trials in France

About this study

Official title: Evaluation of New Computer Vision Methods to Characterize Depression Severity in Patients Hospitalized for Severe Depression.

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).

Conditions
Depression
Being tested
New computer vision methods
Keywords
Psychiatry, prediction, depression, objective psychiatry, personalized treatments, evolution and prognosis, computer science, artificial intelligence, innovation
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • New computer vision methodsBehavioural

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

Study groups in NCT06095310
Study groupRoleWhat they receive
Homogeneous groupsExperimentalNot described
Receives: Behavioral: New computer vision methods

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (1)
  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).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2023
  2. Study start30 Nov 2023
  3. Primary completionNov 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06095310
Sponsor's protocol ID
2021-0366
Other IDs
2022-A01160-43
Acronym
CALYPSO
Status last verified
Apr 2026
First submitted
19 Jul 2023
Last updated
6 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing New computer vision methods in people with Depression, run by University Hospital, Lille at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ali AMAD, MD, PhD (3 20 44 44 60 ext. +33, ali.amad@chu-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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CALYPSO Clinical Trial NCT06095310 | AzTrials