Clinical trial NCT05945342: Development and Application of Comprehensive Intervention Techniques for Adolescent Depression
Official title: Research and Application of Key Technologies for Early Identification, Risk Warning and Comprehensive Intervention of Adolescent Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Adolescent
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 1. 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.
2. To develop a simplified interpersonal psychotherapy technique (IPT-A) for adolescent depression.
3. Research and development of rTMS neuroregulation technology for precise positioning of robot navigation in adolescent depression.
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Score of Child Depression Rating Scale-Revised
timeFrame: Baseline, 2-week, 4-week, 8-week
measure: Score of Beck Scale for Suicide Ideation
timeFrame: Baseline, 2-week, 4-week, 8-week
measure: Score of Iowa Gambling Task
timeFrame: Baseline, 2-week, 8-week
measure: Score of THINC-it test
timeFrame: Baseline, 2-week, 8-week
measure: Hypocretin
timeFrame: Baseline, 2-week, 8-week
measure: Endocannabinoid
timeFrame: Baseline, 2-week, 8-week
measure: Neuroimmune-related factors
timeFrame: Baseline, 2-week, 8-week
measure: Neurotrophic pathway related factors
timeFrame: Baseline, 2-week, 8-week
measure: Near infrared functional imaging of the brain
timeFrame: Baseline, 2-week, 8-week
measure: Change in working memory test scores after intervention
timeFrame: Baseline, 2-week, 8-week, 24-week
measure: Change in three component test of executive function scores after intervention
timeFrame: Baseline, 2-week, 8-week, 24-week
measure: TMS-Evoked potential
timeFrame: Baseline, 2-week, 8-week
measure: Magnetic Resonance Imaging
timeFrame: Baseline, 2-week, 8-week
Secondary outcomes:
measure: Score of 24-item Hamilton Depression Rating Scale
timeFrame: Baseline, 2-week, 4-week, 8-week
measure: Ottawa Self-injury Questionnaire
timeFrame: Baseline, 2-week, 4-week, 8-week
measure: Score of Childhood Trauma Questionnaire
timeFrame: Baseline
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: