Depressive DisorderDALIANCT06789822
Detection Algorithm for Recurrence or Relapse of Depression Thanks to a Smartwach
A study testing Invitation to wear the smartwatch in people with Depressive Disorder and Depressive Disorder, Major Depressive Disorder, run by Dalia Care at 1 site in France.
Trial summary
Globally, 3.8% of the population, or approximately 280 million people, suffer from depression. In France, 12.5% of adults experienced a major depressive episode (MDE) in 2021, with women being twice as affected as men. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- What is being tested?
- Invitation to wear the smartwatch
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 19 Dec 2024to 18 Feb 2026
- 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
- Age ≥ 18 years;
- Patient in remission or recovery from a major depressive episode (MDE), confirmed by a psychiatrist with a Montgomery and Åsberg Depression Rating Scale (MADRS) score ≤ 7, within a maximum of 6 months after the last MDE;
- Patient speaks French;
- Patient owns a smartphone, computer, or tablet with internet/cellular data access;
- Patient resides in France and is affiliated with a social security scheme.
Who cannot join
- Patient taking non-cardioselective beta-blockers (carvedilol, labetalol, propranolol, pindolol) and beta-mimetics (salbutamol, terbutaline);
- Patient with a pacemaker or known cardiac rhythm disorder;
- Patient with substance use disorders in the past six months (alcohol or drug abuse);
- Patient with dementia, mental disorders, cognitive impairments, or psychiatric conditions that could compromise their participation in the study and/or adherence to the study protocol: suicide risk, dementia, schizophrenia or other psychotic disorders, bipolar disorder, anxiety disorders including panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder, psychotic depression, or depression secondary to brain disorders;
- Patient under guardianship, curatorship, or any other administrative or judicial measure restricting rights and freedom;
- Patient deemed non-autonomous by the investigator;
- Patient unable to wear the smartwatch for the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Calibration of the Early Detection Algorithm for Recurrence or Relapse of a Major Depressive Episode Via Clinical Biomarkers Collected by a Smartwatch
Globally, 3.8% of the population, or approximately 280 million people, suffer from depression. In France, 12.5% of adults experienced a major depressive episode (MDE) in 2021, with women being twice as affected as men. MDEs often require pharmacological treatment, but only one-third of patients achieve full remission after eight weeks of treatment. Relapse and recurrence are common, especially after the first episode, with the risk increasing with each subsequent episode. Depression significantly impacts morbidity, mortality, and functioning, and is the leading predictor of suicide.
The Dalia mobile application, developed collaboratively with patients and psychiatrists, uses a smartwatch to monitor physiological parameters (e.g., heart activity, sleep quality, moods) to detect early signs of relapse or recurrence. This study aims to identify variations in clinical biomarkers during remission or recovery and validate Dalia's sensitivity in detecting relapse compared to psychiatric diagnosis. Early detection could improve depression management and reduce the burden of the disease.
Read the detailed description
Globally, it is estimated that 3.8% of the population suffers from depression, amounting to approximately 280 million people.
In France, 12.5% of individuals aged 18-85 years had a history of a major depressive episode (MDE) within the past 12 months in 2021. In 2017, the prevalence of MDE over the previous 12 months was 8.2% among the actively employed French population. Women exhibited a prevalence rate twice as high as men (11.4% vs. 5.3%). Moderate and severe MDEs accounted for 95% of all MDEs, regardless of gender.
A first depressive episode may be isolated and resolve spontaneously within six to nine months without specific treatment. However, in most cases, pharmacological treatment is necessary. Generally, after eight weeks of well-conducted pharmacological treatment, one-third of patients achieve full remission of symptoms, another third partial remission, and the remaining third do not respond to treatment.
Following a first depressive episode, about half of the patients will experience a relapse (a reactivation of the ongoing depressive episode, not fully resolved during the remission period) or a recurrence (a depressive state occurring after the patient was deemed recovered), with most cases happening within the first six months.
The relapse rate increases further with each decompensation. With each additional episode, the risk of relapse or recurrence rises to up to 90% in individuals with three or more episodes.
Depressive disorder is the main predictor of suicide, with one million lives lost annually. Depressive episodes are associated with an increased risk of suicide, morbidity, and mortality. Chronic depression exacerbates the impact of other diseases such as cancer and cardiovascular diseases, with approximately 60% of individuals experiencing severe and lasting impairment in their functioning. More than half of depressive patients will develop multiple episodes, characterized by emotional suffering and despair. Over the past decades, the efficacy of antidepressant treatments has remained stable. About half of the patients remain depressed after initial treatment with psychological or pharmacological therapies, and treatments reduce only one-third of the disease burden.
Detecting depression as early as possible could improve the management of depressive patients, which is currently not feasible. Over the past decade, the development of digital applications and the market introduction of wearable devices have offered new opportunities to continuously evaluate physical and psychological parameters. Detection algorithms do not aim to identify new risk factors; rather, they combine multiple known predictors to estimate individual risk. During a major depressive episode, several physical and physiological parameters (heart activity, sleep quality, daily moods) are disrupted. A more precise understanding of these parameters and their variations would allow better characterization of depressive patients and early detection of relapse/recurrence through monitoring.
Dalia is a mobile application designed by caregivers in close collaboration with patients and psychiatrists to continuously collect and monitor physiological data via a smartwatch, with the aim of early detection of signs of relapse or recurrence. Early detection of relapse and recurrence risk in MDEs could enable timely management. Although factors for relapse or recurrence have been widely documented, the threshold for variations in physiological (clinical) parameters in a tool detecting relapse or recurrence has not been established.
In this study, a set of clinical variables considered potential factors for detecting relapse or recurrence in MDEs will be measured, and their variations will be assessed. These physiological biomarkers will be collected from patients in remission or recovery from a major depressive episode via a smartwatch. We hypothesize that relapse detected by the Dalia device can be correctly adjusted to relapse diagnosis confirmed by a psychiatrist, with high sensitivity and a low false-negative rate.
- Conditions
- Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- Being tested
- Invitation to wear the smartwatch
- Keywords
- Algorithm, Early Detection, Recurrence, Relapse, Major Depressive Episode, Clinical Biomarker, Smartwatch
- Medical subject headings
- Depressive Disorder, Depressive Disorder, Major, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Invitation to wear the smartwatchDevice
During a consultation with the psychiatrist, and after verifying the eligibility criteria, the patient will receive oral information about the study from the psychiatrist.
| Study group | Role | What they receive |
|---|---|---|
| Patients included | Experimental | The Arm of patients invited to wear smartwatch during the study Receives: Device: Invitation to wear the smartwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients with Relapse (during remission) or Recurrence (after Recovery)
Detection of a relapse (during remission) or a recurrence (after recovery) in patients in remission or recovery from a major depressive episode (MDE), using physiological (clinical) data collected via a smartwatch.
Measured: From enrollment to the end of calibration at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start19 Dec 2024
- Primary completion18 Aug 2025 (estimated)
- Study completion18 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive DisorderStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an observational, prospective, multicenter study (data collection). The data collected will be derived from information obtained as part of routine care.
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dalia Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Digital Medical Hub
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789822
- Sponsor's protocol ID
- 2024-A01982-45
- Acronym
- DALIA
- Status last verified
- Jan 2025
- First submitted
- 17 Jan 2025
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are under European Regulation (GDPR 2016) and we have no permission to share them
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calibration of the Early Detection Algorithm for Recurrence or Relapse of a Major Depressive Episode Via Clinical Biomarkers Collected by a Smartwatch
- ClinicalTrials.gov ID
- NCT06789822
- Acronym / sponsor ID
- DALIA / 2024-A01982-45
- Conditions
- Depressive Disorder, Depressive Disorder, Major Depressive Disorder, Depressive Disorder Not Otherwise Specified (NOS)
- Keywords
- Algorithm, Early Detection, Recurrence, Relapse, Major Depressive Episode, Clinical Biomarker, Smartwatch
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Dalia CareIndustry (pharma, biotech, devices)
- Collaborators
- Digital Medical Hub
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 18 Feb 2026 (estimated)
- First posted
- 23 Jan 2025 (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.
Globally, 3.8% of the population, or approximately 280 million people, suffer from depression. In France, 12.5% of adults experienced a major depressive episode (MDE) in 2021, with women being twice as affected as men. MDEs often require pharmacological treatment, but only one-third of patients achieve full remission after eight weeks of treatment. Relapse and recurrence are common, especially after the first episode, with the risk increasing with each subsequent episode. Depression significantly impacts morbidity, mortality, and functioning, and is the leading predictor of suicide.
The Dalia mobile application, developed collaboratively with patients and psychiatrists, uses a smartwatch to monitor physiological parameters (e.g., heart activity, sleep quality, moods) to detect early signs of relapse or recurrence. This study aims to identify variations in clinical biomarkers during remission or recovery and validate Dalia's sensitivity in detecting relapse compared to psychiatric diagnosis. Early detection could improve depression management and reduce the burden of the disease.
Detailed description
Globally, it is estimated that 3.8% of the population suffers from depression, amounting to approximately 280 million people.
In France, 12.5% of individuals aged 18-85 years had a history of a major depressive episode (MDE) within the past 12 months in 2021. In 2017, the prevalence of MDE over the previous 12 months was 8.2% among the actively employed French population. Women exhibited a prevalence rate twice as high as men (11.4% vs. 5.3%). Moderate and severe MDEs accounted for 95% of all MDEs, regardless of gender.
A first depressive episode may be isolated and resolve spontaneously within six to nine months without specific treatment. However, in most cases, pharmacological treatment is necessary. Generally, after eight weeks of well-conducted pharmacological treatment, one-third of patients achieve full remission of symptoms, another third partial remission, and the remaining third do not respond to treatment.
Following a first depressive episode, about half of the patients will experience a relapse (a reactivation of the ongoing depressive episode, not fully resolved during the remission period) or a recurrence (a depressive state occurring after the patient was deemed recovered), with most cases happening within the first six months.
The relapse rate increases further with each decompensation. With each additional episode, the risk of relapse or recurrence rises to up to 90% in individuals with three or more episodes.
Depressive disorder is the main predictor of suicide, with one million lives lost annually. Depressive episodes are associated with an increased risk of suicide, morbidity, and mortality. Chronic depression exacerbates the impact of other diseases such as cancer and cardiovascular diseases, with approximately 60% of individuals experiencing severe and lasting impairment in their functioning. More than half of depressive patients will develop multiple episodes, characterized by emotional suffering and despair. Over the past decades, the efficacy of antidepressant treatments has remained stable. About half of the patients remain depressed after initial treatment with psychological or pharmacological therapies, and treatments reduce only one-third of the disease burden.
Detecting depression as early as possible could improve the management of depressive patients, which is currently not feasible. Over the past decade, the development of digital applications and the market introduction of wearable devices have offered new opportunities to continuously evaluate physical and psychological parameters. Detection algorithms do not aim to identify new risk factors; rather, they combine multiple known predictors to estimate individual risk. During a major depressive episode, several physical and physiological parameters (heart activity, sleep quality, daily moods) are disrupted. A more precise understanding of these parameters and their variations would allow better characterization of depressive patients and early detection of relapse/recurrence through monitoring.
Dalia is a mobile application designed by caregivers in close collaboration with patients and psychiatrists to continuously collect and monitor physiological data via a smartwatch, with the aim of early detection of signs of relapse or recurrence. Early detection of relapse and recurrence risk in MDEs could enable timely management. Although factors for relapse or recurrence have been widely documented, the threshold for variations in physiological (clinical) parameters in a tool detecting relapse or recurrence has not been established.
In this study, a set of clinical variables considered potential factors for detecting relapse or recurrence in MDEs will be measured, and their variations will be assessed. These physiological biomarkers will be collected from patients in remission or recovery from a major depressive episode via a smartwatch. We hypothesize that relapse detected by the Dalia device can be correctly adjusted to relapse diagnosis confirmed by a psychiatrist, with high sensitivity and a low false-negative rate.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an observational, prospective, multicenter study (data collection). The data collected will be derived from information obtained as part of routine care.
| Arm | Type | Receives |
|---|---|---|
| Patients included | Experimental | Device: Invitation to wear the smartwatchThe Arm of patients invited to wear smartwatch during the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years;
- Patient in remission or recovery from a major depressive episode (MDE), confirmed by a psychiatrist with a Montgomery and Åsberg Depression Rating Scale (MADRS) score ≤ 7, within a maximum of 6 months after the last MDE;
- Patient speaks French;
- Patient owns a smartphone, computer, or tablet with internet/cellular data access;
- Patient resides in France and is affiliated with a social security scheme.
Key exclusion criteria (7 listed)
- Patient taking non-cardioselective beta-blockers (carvedilol, labetalol, propranolol, pindolol) and beta-mimetics (salbutamol, terbutaline);
- Patient with a pacemaker or known cardiac rhythm disorder;
- Patient with substance use disorders in the past six months (alcohol or drug abuse);
- Patient with dementia, mental disorders, cognitive impairments, or psychiatric conditions that could compromise their participation in the study and/or adherence to the study protocol: suicide risk, dementia, schizophrenia or other psychotic disorders, bipolar disorder, anxiety disorders including panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder, psychotic depression, or depression secondary to brain disorders;
- Patient under guardianship, curatorship, or any other administrative or judicial measure restricting rights and freedom;
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 |
|---|---|---|
| Invitation to wear the smartwatchDuring a consultation with the psychiatrist, and after verifying the eligibility criteria, the patient will receive oral information about the study from the psychiatrist. | Device | Patients included |
Primary outcome
Number of Patients with Relapse (during remission) or Recurrence (after Recovery)
Time frame: From enrollment to the end of calibration at 8 months
Detection of a relapse (during remission) or a recurrence (after recovery) in patients in remission or recovery from a major depressive episode (MDE), using physiological (clinical) data collected via a smartwatch.
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 23 Jan 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. IPD are under European Regulation (GDPR 2016) and we have no permission to share them
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Invitation to wear the smartwatch in people with Depressive Disorder and Depressive Disorder, Major Depressive Disorder, run by Dalia Care 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 23 Jan 2025. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients with Relapse (during remission) or Recurrence (after Recovery) (time frame: From enrollment to the end of calibration at 8 months). 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 23 Jan 2025.