Wearable Devices System Diagnoses Mood Disorder in Children and Adolescents

Recruiting

• Conditions: Mood Disorders; Diagnosis, Psychiatric

• Registration Number: NCT06213220
• Lead Sponsor: Institute of Psychology, Chinese Academy of Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-03
• Status Verified: 2023-11
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2024-01-09
• Study First Posted: 2024-01-19
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-06
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
R-R interval	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.	the interval between heart beats derived from Photoplethysmography (PPG)
Hamilton Depression Rating Scale (HAM-D)	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.	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.
Young Mania Rating Scale (YMRS)	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.	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

Trial Locations

Locations (1)

Institute of Psychology, Chinese Academy of Sciences; 🇨🇳 Beijing, China