Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Score of Child Depression Rating Scale-Revised
研究概览
简要总结
In order to realize the early identification, risk warning and comprehensive intervention of adolescent depression, this project carried out research on the diagnosis platform of adolescent depression, the construction of suicide risk warning and evaluation system, the development of interpersonal psychotherapy technology (IPT-A), and the rapid intervention technology of robotic navigation repetitive transcranial magnetic stimulation (rTMS). Through the extraction of psychological, peripheral and central biological characteristics of adolescent depression and the establishment of a diagnostic platform, combined with artificial neural network to achieve efficient and accurate identification of high risk of suicide population. Antidepressant drugs combined with psychotherapy and antidepressant drugs combined with rTMS physical therapy were used to improve the clinical effective rate and recovery rate. Finally, a comprehensive prevention and control technology suitable for hospitals, schools and families to participate in.
详细描述
- The interaction of symptoms, psychological indicators (including environmental risk factors and neuropsychology), peripheral biology (peripheral neuroimmunity, neurotrophic factors and neuroendocrine related indicators), central biological indicators (neuroimaging, near-infrared functional brain imaging) and brain-derived exosome detection in peripheral blood was constructed based on artificial intelligence technology The network of clinical diagnosis platform, and according to the high and low suicide risk classification of deep learning, the establishment of adolescent depression early identification and suicide risk warning system.
- To develop a simplified interpersonal psychotherapy technique (IPT-A) for adolescent depression.
- Research and development of rTMS neuroregulation technology for precise positioning of robot navigation in adolescent depression.
- Construct comprehensive intervention models and efficacy prediction models for adolescent depression, such as drug combined with psychology and drug combined with physical therapy, and promote and demonstrate the application.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Sign a written informed consent to participate in the trial and receive treatment;
- Meet the diagnostic criteria of depression in DSM-5, and have no psychotic characteristics;
- Child Depression Rating Scale-Revised (CRs-R)≥40 points;
- 24 Hamilton Depression Scale (HAMD-24) scores ≥20;
- First or recurrent depressive episode, not received antidepressant drugs and systematic psychotherapy in recent 2 months;
- The Han nationality, right hand
排除标准
- Have other mental disorders, or have a history of other mental disorders, such as attention deficit movement disorder, autism, and developmental retardation;
- Patients with current infections, trauma, autoimmune diseases, other unstable medical conditions, or who are receiving hormone therapy;
- Patients with a history of craniocerebral injury and coma;
- A family history of bipolar disorder, seizures, or epilepsy;
- Those who had substance abuse or dependence within the first three months of enrollment;
- Patients with contraindications for MRI examination such as metal foreign body in the skull or abnormal brain structure found in MRI examination.
研究组 & 干预措施
Simple Psychotherapy
Simple interpersonal psychotherapy group
干预措施: Interpersonal Psychotherapy for Adolescent (Other)
Medication combined with psychotherapy
Medication combined with interpersonal psychotherapy
干预措施: Escitalopram combined with psychotherapy (Other)
Medication combined with physical therapy group
Medication combined with robotic navigational repetitive transcranial magnetic stimulation
干预措施: Escitalopram combined with rTMS (Other)
Medication combined with sham physical therapy group
Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation
干预措施: Escitalopram combined with sham rTMS (Drug)
Simple Medication
Escitalopram alone treatment
干预措施: Escitalopram (Drug)
结局指标
主要结局
Score of Child Depression Rating Scale-Revised
时间窗: Baseline, 2-week, 4-week, 8-week
For clinical depression symptom assessment
Score of Beck Scale for Suicide Ideation
时间窗: Baseline, 2-week, 4-week, 8-week
For the quantitative assessment of suicidal ideation
Score of Iowa Gambling Task
时间窗: Baseline, 2-week, 8-week
The simulation of the real decision situation is a kind of decision making task in the fuzzy situation accompanied by corresponding rewards and punishments
Score of THINC-it test
时间窗: Baseline, 2-week, 8-week
The test includes Spotter, Symbol check, Codebreaker, Trails, and the 5-item Depression Cognitive Deficit Questionnaire (PDQ-5-D). It is used to assess working memory, executive function and attention
Hypocretin
时间窗: Baseline, 2-week, 8-week
Hypocretin is a neurotransmitter that regulates wakefulness and appetite
Endocannabinoid
时间窗: Baseline, 2-week, 8-week
Endocannabinoid play an important role in regulating many functions in the body, including the inflammatory system, immune function, sleep, appetite, digestion, pain receptors, hormones, reproductive function and memory
Neuroimmune-related factors
时间窗: Baseline, 2-week, 8-week
Such as IL-lβ、IL-6、TNF-α
Neurotrophic pathway related factors
时间窗: Baseline, 2-week, 8-week
Such as BDNF、VGF、TrkB、tPA
Near infrared functional imaging of the brain
时间窗: Baseline, 2-week, 8-week
Near infrared functional brain imaging can reflect the activation degree of brain function and functional connectivity of brain by detecting the concentration changes of oxygenated hemoglobin and deoxygenated hemoglobin in the target brain area.
Change in working memory test scores after intervention
时间窗: Baseline, 2-week, 8-week, 24-week
The working memory test consists of two parts, which measure the breadth and accuracy of working memory respectively. The breadth of working memory will be tested using the operating span experiment, as the accuracy of working memory will be tested using the Memory Orientation experiment
Change in three component test of executive function scores after intervention
时间窗: Baseline, 2-week, 8-week, 24-week
The three component tests of executive function were one-backward test, anti-saccade and shifting test respectively.In the one-backward test, subjects need to memorize letters while counting numbers, scoring them according to the accuracy of the alphabetic memory order; The anti-saccade test asks subjects to react to a flash of arrows (0.5 seconds) by selecting the direction they see on a keyboard；The shifting test asked subjects to select a forward or reverse feedback key depending on where the icon appeared
TMS-Evoked potential
时间窗: Baseline, 2-week, 8-week
The integration of transcranial magnetic stimulation (TMS) and electroencephalography (EEG) is a valuable method for directly probing excitability, connectivity and oscillatory dynamics of regions throughout the brain. Offering in depth measurement of cortical reactivity, TMS-EEG allows the evaluation of TMS-evoked components that may act as a marker for cortical excitation and inhibition.
Magnetic Resonance Imaging
时间窗: Baseline, 2-week, 8-week
Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes
次要结局
- Score of 24-item Hamilton Depression Rating Scale(Baseline, 2-week, 4-week, 8-week)
- Ottawa Self-injury Questionnaire(Baseline, 2-week, 4-week, 8-week)
- Score of Childhood Trauma Questionnaire(Baseline)
研究者
研究点 (1)
标识符
- NCT 编号
- NCT05945342
- 其他研究编号
- IIT2023510
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (去年)
- 研究完成日期
- (去年)
- 最近核实
- 最近更新
- (2年前)
监管与共享
- FDA 监管药物
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否