Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents

NCT ID: NCT06213220

Last Updated: 2024-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-08-31

Brief Summary

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As a diagnostic test, this study aims to explore the effectiveness of systems based on wearable devices in identifying mood disorders in children and adolescents.

Detailed Description

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Conditions

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Mood Disorders Diagnosis, Psychiatric

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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mood disorders group

Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement.

No interventions assigned to this group

healthy control group

Participants are requested to wear the wristbands throughout the experiment, and upload their data every three days. Additionally, the Hamilton Depression Rating Scale (HAMD) and the Young Mania Rating Scale (YMRS) are administered once a week for measurement.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects in the MDD group met the DSM-5 diagnostic criteria for MDD and those in the BD group met the DSM-5 criteria for BD
* able to cooperate to complete the study
* had signed the informed consent prior to the study

Exclusion Criteria

* with severe physical illness
* demonstrated symptoms comorbid with other psychiatric disorders (e.g., schizophrenia, conduct disorder, personality disorder) and developmental disorders (e.g., autism spectrum disorder, intellectual impairment)
* other conditions deemed inappropriate for inclusion in the group
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Institute of Psychology, Chinese Academy of Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Psychology, Chinese Academy of Sciences

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fenghua Li, Ph.D

Role: CONTACT

+86 13671258804

Zhengkui Liu, Ph.D

Role: CONTACT

Facility Contacts

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Fenghua Li, Ph.D

Role: primary

Other Identifiers

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E2KM011639-MDCA

Identifier Type: -

Identifier Source: org_study_id

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