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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Recruiting
Hôpital Fontan 1 - CHU de Lille
Lille, 59000
DRI, 320444145 ext. +33, drs.promotion@chu-lille.fr
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 group | Role | What they receive |
|---|---|---|
| Homogeneous groups | Experimental | Not described Receives: Behavioral: New computer vision methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
- First posted23 Oct 2023
- Study start30 Nov 2023
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali AMAD, MD, PhD, Principal investigator, University Hospital, Lille
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
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Computer Vision Methods to Characterize Depression Severity in Patients Hospitalized for Severe Depression.
- ClinicalTrials.gov ID
- NCT06095310
- Acronym / sponsor ID
- CALYPSO / 2021-0366
- Conditions
- Depression
- Keywords
- Psychiatry, prediction, depression, objective psychiatry, personalized treatments, evolution and prognosis, computer science, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Homogeneous groups | Experimental | Behavioral: New computer vision methods |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New computer vision methodsClinical interview: Hamilton scale using multi-modal sensors (cameras, audio, bracelet, fNIRS) | Behavioural | Homogeneous groups |
Primary outcome
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).
1 secondary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali AMAD, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
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.