Major Depressive DisorderNCT05400785
Efficacy of the Mobile Application for Prediction and Prevention of Mood Episode Recurrence Based on Machine Learning
A study testing Circadian Rhythms for Mood (CRM) application - Active in people with Major Depressive Disorder and Bipolar 1 Disorder, run by Hucircadian at 1 site in South Korea.
Trial summary
This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar 1 Disorder, Bipolar II Disorder
- What is being tested?
- Circadian Rhythms for Mood (CRM) application - Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 May 2022to 21 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients, 19-70 years old
- Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
- Android smartphone users, capable of installing and executing the CRM application
- Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly
Who cannot join
- Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
- Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
- Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
- Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
- Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of the Mobile Phone Application (Circadian Rhythms for Mood) for Prediction and Prevention of Mood Episode Recurrence in Mood Disorders Based on Machine Learning of Daily Digital Phenotype Variables : A Sham-controlled Randomized Clinical Trial
This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.
- Being tested
- Circadian Rhythms for Mood (CRM) application - Active, Circadian Rhythms for Mood (CRM) application - Sham
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Rhythms for Mood (CRM) application - ActiveOther
The study subjects participating in this clinical trial wear wearable activity tracker 24 hours a day for a continuous period of time and run the CRM app once a day to check their conditions (feelings, vitality, sleep, etc.) in the Daily Symptom Assessment (eMoodChart). The active intervention group are provided with mood prediction results and instructions as feedback through the 'life report' and push notification in the application.
Circadian Rhythms for Mood (CRM) application - ShamOther
The study subjects assigned to the sham intervention group are provided with feedbacks operated by dummy algorithm. The application is visually indistinguishable from active CRM, and it is designed to minimize behavioral change.
| Study group | Role | What they receive |
|---|---|---|
| Active CRM | Active comparator | Not described Receives: Other: Circadian Rhythms for Mood (CRM) application - Active |
| Sham CRM | Sham comparator | Not described Receives: Other: Circadian Rhythms for Mood (CRM) application - Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of total number of recurrent mood episodes between the active and sham groups
We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.
Measured: 12 months
Comparison of duration of mood episodes between the active and sham groups
We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start27 May 2022
- Primary completion21 Dec 2023
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hucircadian
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Guro Hospital, Korea University Ansan Hospital, Pusan National University Hospital, Inje University Ilsan Paik Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400785
- Sponsor's protocol ID
- HC-CRM-01
- Status last verified
- Mar 2025
- First submitted
- 27 May 2022
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yeom JW, Yoon Y, Seo JY, Cho CH, Lee T, Lee JB, Jeon S, Kim L, Lee HJ. Daily Self-Monitoring and Feedback of Circadian Rhythm Measures in Major Depression and Bipolar Disorder Using Wearable Devices and Smartphones-The Circadian Rhythm for Mood (CRM(R)) Trial Protocol: A Randomized Sham Controlled Double-Blind Trial. Psychiatry Investig. 2024 Aug;21(8):918-924. doi: 10.30773/pi.2024.0133. Epub 2024 Aug 2.
PubMed 39086163
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of the Mobile Phone Application (Circadian Rhythms for Mood) for Prediction and Prevention of Mood Episode Recurrence in Mood Disorders Based on Machine Learning of Daily Digital Phenotype Variables : A Sham-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05400785
- Acronym / sponsor ID
- HC-CRM-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- HucircadianIndustry (pharma, biotech, devices)
- Collaborators
- Korea University Guro Hospital, Korea University Ansan Hospital, Pusan National University Hospital, Inje University Ilsan Paik Hospital
- Study start
- 27 May 2022 (actual)
- Primary completion
- 21 Dec 2023 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 2 Jun 2022 (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.
This study was designed to evaluate the efficacy of the mobile application named Circadian Rhythm for Mood (CRM), which was developed to prevent recurring episodes of mood disorders (major depressive disorders, bipolar disorders type 1 and 2) based on machine learning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active CRM | Active comparator | Other: Circadian Rhythms for Mood (CRM) application - Active |
| Sham CRM | Sham comparator | Other: Circadian Rhythms for Mood (CRM) application - Sham |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female patients, 19-70 years old
- Diagnosis with Bipolar I disorder, Bipolar II disorder, Major depressive disorder based on DSM-5 criteria, in euthymic state for more than two weeks at the time of the recruitment
- Android smartphone users, capable of installing and executing the CRM application
- Consent to wear wearable device (Fitbit) continuously and synchronize and backup data regularly
Key exclusion criteria (5 listed)
- Patients who have not experienced major depressive, manic, or hypomanic episode in the last two years
- Patients who are difficult to specify mood episode or evaluate symptoms of mood episode independently due to personality traits (borderline personality trait, cyclothymic temperament, etc.)
- Patients with degenerative neurological disorders (Parkinson's disease, dementia, Huntington's disease, etc.), neurodevelopmental disorders (intellectual disorder, autism spectrum disorder, down syndrome, etc.), epilepsy, severe traumatic brain damage, stroke, and other brain neurological disorders
- Inmates or patients who are forced into custody for the treatment of mental or physical illness (non-voluntary isolation or hospitalization)
- Patients with difficulties in understanding the objectives and process of the study and the potential benefits and risks of participating in the study
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 |
|---|---|---|
| Circadian Rhythms for Mood (CRM) application - ActiveThe study subjects participating in this clinical trial wear wearable activity tracker 24 hours a day for a continuous period of time and run the CRM app once a day to check their conditions (feelings, vitality, sleep, etc.) in the Daily Symptom Assessment (eMoodChart). The active intervention group are provided with mood prediction results and instructions as feedback through the 'life report' and push notification in the application. | Other | Active CRM |
| Circadian Rhythms for Mood (CRM) application - ShamThe study subjects assigned to the sham intervention group are provided with feedbacks operated by dummy algorithm. The application is visually indistinguishable from active CRM, and it is designed to minimize behavioral change. | Other | Sham CRM |
Primary outcome
Comparison of total number of recurrent mood episodes between the active and sham groups
Time frame: 12 months
We aim to evaluate the efficacy of reducing recurrence rate of mood episodes through the CRM mobile application.
Comparison of duration of mood episodes between the active and sham groups
Time frame: 12 months
We aim to evaluate the efficacy of reducing duration of mood episodes through the CRM mobile application.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2025.
- Derived from this study: PubMed 39086163Yeom JW, Yoon Y, Seo JY, Cho CH, Lee T, Lee JB, Jeon S, Kim L, Lee HJ. Daily Self-Monitoring and Feedback of Circadian Rhythm Measures in Major Depression and Bipolar Disorder Using Wearable Devices and Smartphones-The Circadian Rhythm for Mood (CRM(R)) Trial Protocol: A Randomized Sham Controlled Double-Blind Trial. Psychiatry Investig. 2024 Aug;21(8):918-924. doi: 10.30773/pi.2024.0133. Epub 2024 Aug 2.
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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 Circadian Rhythms for Mood (CRM) application - Active in people with Major Depressive Disorder and Bipolar 1 Disorder, run by Hucircadian at 1 site in South Korea.
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 5 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: finished, as of the sponsor's last update on 17 Mar 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparison of total number of recurrent mood episodes between the active and sham groups (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05400785, which also lists 1 linked publication.
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 17 Mar 2025.