Development and Application of Comprehensive Intervention Techniques for Adolescent Depression

Zhejiang University

Status: Enrolling

Conditions: Adolescent; Depressive Disorder

Treatments: Drug: Escitalopram combined with sham rTMS; Other: Escitalopram combined with rTMS; Other: Interpersonal Psychotherapy for Adolescent; Other: Escitalopram combined with psychotherapy; Drug: Escitalopram

Study type: Interventional

Funder types: Other

Identifiers

NCT05945342

IIT2023510

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 5 patient groups

Simple Medication

Active Comparator group

Description:

Escitalopram alone treatment

Treatment:

Drug: Escitalopram

Simple Psychotherapy

Active Comparator group

Description:

Simple interpersonal psychotherapy group

Treatment:

Other: Interpersonal Psychotherapy for Adolescent

Medication combined with psychotherapy

Experimental group

Description:

Medication combined with interpersonal psychotherapy

Treatment:

Other: Escitalopram combined with psychotherapy

Medication combined with physical therapy group

Experimental group

Description:

Medication combined with robotic navigational repetitive transcranial magnetic stimulation

Treatment:

Other: Escitalopram combined with rTMS

Medication combined with sham physical therapy group

Sham Comparator group

Description:

Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation

Treatment:

Drug: Escitalopram combined with sham rTMS