Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents

NCT06213220 | Unknown

• 1 other identifier: E2KM011639-MDCA
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mood Disorders; Diagnosis, Psychiatric

Outcome Measures

Primary Outcomes (3)

• R-R interval

  the interval between heart beats derived from Photoplethysmography (PPG)

  In the experiment conducted over a period of four weeks, the sampling frequency was 25Hz (based on seconds).The report will be available approximately one year after the end of the experiment.

• Hamilton Depression Rating Scale (HAM-D)

  Hamilton Depression Rating Scale (HAM-D) is the most widely used clinician-administered depression assessment scale. The original HAM-D has 21 items, but scoring is based only on the first 17. The patient is rated by a clinician on 17 items scored on a 5-point Likert-type scale. The total score ranges from 0 to 68. A score of 0-7 is considered to be normal while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.

  In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.

• Young Mania Rating Scale (YMRS)

  The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. Additional information is based upon clinical observations made during the course of the clinical interview. The items are selected based upon published descriptions of the core symptoms of mania. The YMRS follows the style of the Hamilton Rating Scale for Depression (HAM-D) with each item given a severity rating. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. Here's a quick list of what each score range may indicate in a patient: Less than or equal to 12 = remission; 13 -19 = minimal symptoms; 20 - 25 = mild mania; 26 - 37 = moderate mania; 38 - 60 = severe mania

  In the experiment conducted over a period of four weeks, data collection was performed once per week. The report will be available approximately one year after the end of the experiment.

Other Outcomes (3)

• sensitivity

  The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.

• specificity

  The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.

• accuracy

  The model fitting will be completed approximately 6 months after the end of the experiment. The report will be available approximately one year after the end of the experiment.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

children and adolescents mood disorders patients and healthy controls age between 6 - 16 boys and girls

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Institute of Psychology, Chinese Academy of Sciences: lead

Study Sites (1)

Institute of Psychology, Chinese Academy of Sciences

Beijing, China

RECRUITING

MeSH Terms

Conditions

Mood Disorders; Mental Disorders

Central Study Contacts

Fenghua Li, Ph.D

CONTACT

+86 13671258804; lifh@psych.ac.cn

Zhengkui Liu, Ph.D

CONTACT

liuzk@psych.ac.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: January 19, 2024
• Study Start: January 3, 2023
• Primary Completion: June 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 1, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)