Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Smartphone data may predict depression relapse before it happens

NCT ID NCT07151846

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study is testing whether data from smartphones and wearable devices can predict when a person with depression or bipolar disorder might have another episode. Over 12 months, 540 participants will wear a Fitbit, log daily moods, and complete five check-ins. Researchers will use this data to build AI models that could one day warn of an upcoming relapse.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a way to predict when someone with depression or bipolar disorder might have a relapse, allowing for earlier help.
What could go wrong
This is an early-stage observational study, not a treatment trial. The digital models may not be accurate enough to predict real-world relapses, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 540 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This study will recruit a total of 540 participants divided into three groups: Patient Group (PT, n=200): Individuals diagnosed with a mood disorder (bipolar I/II or major depressive disorder) who have experienced at least one depressive episode within the past two years. High-Risk Group (HR): Individuals with no formal mood disorder diagnosis but who present subclinical mood symptoms or elevated screening scores suggesting potential risk for affective disorders. Healthy Control Group (HC): Individuals with no history or current diagnosis of any mood disorder and who do not show clinically significant symptoms on screening assessments. All participants will undergo 5 clinical assessments over a 12-month period (every 3 months) and will be asked to wear a Fitbit device daily and record their mood daily via a mobile app throughout the study. No therapeutic intervention will be provided, and the study does not involve randomization or blinding.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria for Patient Group: 1. Adults aged 19 to 75 years and 11 months. 2. Diagnosed with a major mood disorder (bipolar I or II disorder, or major depressive disorder) based on DSM-5, with a history of psychiatric visits for mood symptoms. 3. Has experienced at least one prior depressive episode (major, minor, or brief). 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Inclusion Criteria for Healthy Control Group: 1. Adults aged 19 to 75 years and 11 months. 2. No current or past diagnosis of bipolar disorder or major depressive disorder. 3. Scores below clinical thresholds on both K-MDQ (\<7) and PHQ-9 (\<5) at baseline assessment. 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Inclusion Criteria for Hight Risk Group: 1. Adults aged 19 to 75 years and 11 months. 2. No current or past diagnosis of bipolar disorder or major depressive disorder. 3. Meets either of the following: A. Scores above the threshold on K-MDQ (≥7) or PHQ-9 (≥5) at baseline. B. Reports persistent mood symptoms during MINI (e.g., ≥2 weeks of depressive mood/anhedonia, or several days of elevated/irritable mood). 4. Owns a smartphone with stable internet connectivity, can operate it without difficulty, and agrees to install a digital phenotyping application, wear a Fitbit device daily, and complete daily mood logs throughout the study period. Exclusion Critera (Overall) 1. Inability to provide informed consent due to cognitive impairment, severe psychiatric symptoms, or language barriers. 2. Presence of any neurological or medical condition that may significantly affect mood, cognition, or behavior (e.g., epilepsy, dementia, traumatic brain injury). 3. Current substance use disorder or dependence (excluding nicotine or caffeine) that is either untreated or clinically unstable. 4. Severe suicidal ideation or risk as determined by clinical judgment at screening. 5. Ongoing participation in another interventional clinical trial, particularly those involving psychotropic medications or digital health interventions. 6. Inability or unwillingness to wear a wearable device (Fitbit) or use the required mobile application daily throughout the study. 7. Lack of stable internet access or a compatible smartphone required for digital phenotyping data collection. 8. Any other condition that, in the investigator's judgment, may compromise the participant's safety, compliance, or the integrity of the study data.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Bipolar disorder (BD) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Korea University Anam Hospital

    Seoul, Seongbuk-gu, 02841, South Korea

More trials for these conditions

Other studies related to the condition(s) this trial covers.