Digital Phenotypes for Predicting Depression

NCT07151846 | Enrolling By Invitation DMC

• 2 other identifiers: MY MENTAL HERORS-2024-00469788
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

This longitudinal study aims to identify and validate digital phenotypes that can predict recurrence of major depressive episodes using passively collected, real-time sensing data from smartphones and wearable devices. Over a 12-month period, 540 participants-including patients with mood disorders and healthy or high-risk controls-will complete five clinical assessments at 3-month intervals, wear a Fitbit device daily, and log daily mood ratings via a mobile app. The study includes the development of AI-based predictive models and the construction of an anonymized wearable big-data repository for mood disorders.

Conditions

Depression - Major Depressive Disorder; Depression Bipolar; Bipolar Disorder (BD); Mood Disorders

Outcome Measures

Primary Outcomes (5)

• The Patient Health Questionnaire (PHQ-9)

  The Patient Health Questionnaire (PHQ-9) is a self-report screening tool designed to assess the severity of depressive symptoms. PHQ score range is 0 to 27. Higher PHQ score indicates worse depressive symptoms.

  Baseline, month 3, month 6, month 9, month 12

• Inter-visit mood episode occurance

  Mood episodes that occur between scheduled study visits will be assessed by trained raters. If an inter-visit episode is suspected, a structured clinical evaluation will be conducted using standardized case report forms (CRFs) to determine: 1. Episode period (start and end dates), 2. Presence of DSM-5 mood symptoms (e.g., depressed mood, anhedonia, decreased need for sleep, inflated self-esteem), 3. Episode severity as rated by the Clinical Global Impressions (CGI) scale (1-7; higher scores indicate greater severity). Scoring and Interpretation: * CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients). * Higher CGI scores represent worse mood symptom severity. Diagnostic criteria for depressive episodes (≥1 core symptom plus ≥5 symptoms, ≥2 weeks) and (hypo)manic episodes (≥1 core symptom plus ≥3-4 symptoms, ≥4 days) will be applied using the CRF.

  month 3, month 6, month 9, month 12

• MADRS (Montgomery-Åsberg Depression Rating Scale)

  The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered tool used to assess the severity of depressive symptoms. It consists of 10 items rated on a 0-6 scale and is widely used in clinical trials due to its sensitivity to treatment-related change. MADRS score range is 0 to 60. Higher MADRS score indicates worse depressive symptoms.

  Baseline, month 3, month 6, month 9, month 12

• YMRS (Young Mania Rating Scale)

  The Young Mania Rating Scale (YMRS) is a clinician-rated scale used to measure the severity of manic symptoms in individuals with bipolar disorder. It includes 11 items covering mood, behavior, and cognitive functioning, with higher scores indicating greater symptom severity. YMRS score rang is 0 to 60. Higher YMRS score indicates worse manic symptoms.

  Baseline, month 3, month 6, month 9, month 12

• CGI (Clinical Global Impression Scale)

  The Clinical Global Impression (CGI) Scale is a standardized assessment tool used by clinicians to rate overall illness severity (CGI-S). CGI-S is rated on a 7-point scale for each of three components: Depression, Mania, Overall. CGI scale range: 1 (Normal, not ill) to 7 (Among the most extremely ill patients).

  Baseline, month 3, month 6, month 9, month 12

Study Arms (3)

Patient group

Adults (19-75 years) with a clinical diagnosis of a major mood disorder (bipolar I/II or major depressive disorder) per DSM-5, with at least one prior depressive episode.

High Risk

Adults (19-75 years) with no formal diagnosis of bipolar disorder or major depressive disorder, but who meet at least one of the following: 1. Elevated scores at screening (K-MDQ ≥7 or PHQ-9 ≥5), or 2. Report of persistent mood symptoms (e.g., ≥2 weeks of low mood or ≥several days of elevated/irritable mood) during MINI interview.

Healthy Control

Adults (19-75 years) with no current or past diagnosis of bipolar disorder or major depressive disorder, and who screen below cutoff on both K-MDQ (\<7) and PHQ-9 (\<5).

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Adults aged 19 to 75 years and 11 months.
• 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.
• Has experienced at least one prior depressive episode (major, minor, or brief).
• 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.
• Adults aged 19 to 75 years and 11 months.
• No current or past diagnosis of bipolar disorder or major depressive disorder.
• Scores below clinical thresholds on both K-MDQ (\<7) and PHQ-9 (\<5) at baseline assessment.
• 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.
• Adults aged 19 to 75 years and 11 months.
• No current or past diagnosis of bipolar disorder or major depressive disorder.
• 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).
• 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.
• Inability to provide informed consent due to cognitive impairment, severe psychiatric symptoms, or language barriers.
• Presence of any neurological or medical condition that may significantly affect mood, cognition, or behavior (e.g., epilepsy, dementia, traumatic brain injury).

Sponsors & Collaborators

• Korea University Anam Hospital: lead
• Korea University Medicine: collaborator
• Hucircadian: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

Location

MeSH Terms

Conditions

Bipolar Disorder; Mood Disorders

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mental Disorders

Study Officials

• Heon-Jeong Lee, Professor

  Korea University Anam Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: September 3, 2025
• Study Start: February 27, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

KR (1)