A Diagnostic Test of Mood Disorder Recognition in Children and Adolescents Based on Wearable Devices
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- R-R interval
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
R-R interval
时间窗: 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)
时间窗: 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)
时间窗: 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
次要结局
未报告次要终点