Depressive Disorder Clinical Trial
Official title:
Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2025 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years to 18 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
First Affiliated Hospital of Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Score of Child Depression Rating Scale-Revised | For clinical depression symptom assessment | Baseline, 2-week, 4-week, 8-week | |
Primary | Score of Beck Scale for Suicide Ideation | For the quantitative assessment of suicidal ideation | Baseline, 2-week, 4-week, 8-week | |
Primary | Score of Iowa Gambling Task | The simulation of the real decision situation is a kind of decision making task in the fuzzy situation accompanied by corresponding rewards and punishments | Baseline, 2-week, 8-week | |
Primary | Score of THINC-it test | 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 | Baseline, 2-week, 8-week | |
Primary | Hypocretin | Hypocretin is a neurotransmitter that regulates wakefulness and appetite | Baseline, 2-week, 8-week | |
Primary | Endocannabinoid | 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 | Baseline, 2-week, 8-week | |
Primary | Neuroimmune-related factors | Such as IL-lß?IL-6?TNF-a | Baseline, 2-week, 8-week | |
Primary | Neurotrophic pathway related factors | Such as BDNF?VGF?TrkB?tPA | Baseline, 2-week, 8-week | |
Primary | Near infrared functional imaging of the brain | 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. | Baseline, 2-week, 8-week | |
Primary | Change in working memory test scores after intervention | 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 | Baseline, 2-week, 8-week, 24-week | |
Primary | Change in three component test of executive function scores after intervention | 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 | Baseline, 2-week, 8-week, 24-week | |
Primary | TMS-Evoked potential | 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. | Baseline, 2-week, 8-week | |
Primary | Magnetic Resonance Imaging | Functional magnetic resonance brain imaging can reflect the functional and metabolic information of neurons before morphological changes | Baseline, 2-week, 8-week | |
Secondary | Score of 24-item Hamilton Depression Rating Scale | For clinical depression symptom assessment | Baseline, 2-week, 4-week, 8-week | |
Secondary | Ottawa Self-injury Questionnaire | To evaluate the situation of NSSI among adolescents | Baseline, 2-week, 4-week, 8-week | |
Secondary | Score of Childhood Trauma Questionnaire | Used to assess traumatic experiences in childhood | Baseline |
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