Development and Application of Comprehensive Intervention Techniques for Adolescent Depression

NCT ID: NCT05945342

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-31
• Study Completion Date: 2025-06-30

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.

Conditions

Depressive Disorder; Adolescent

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Simple Medication

Escitalopram alone treatment

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression

Simple Psychotherapy

Simple interpersonal psychotherapy group

Group Type: ACTIVE_COMPARATOR

Interpersonal Psychotherapy for Adolescent

Intervention Type: OTHER

Interpersonal Psychotherapy for Adolescent(IPT-A), A modified version of interpersonal psychotherapy, is shorter than the standard therapy duration (12-16 sessions), with a total of eight sessions, retaining the structure of the standard IPT but employing a series of strategies to extract the most important components to speed up the time process.

Medication combined with psychotherapy

Medication combined with interpersonal psychotherapy

Group Type: EXPERIMENTAL

Escitalopram combined with psychotherapy

Intervention Type: OTHER

The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication

Medication combined with physical therapy group

Medication combined with robotic navigational repetitive transcranial magnetic stimulation

Group Type: EXPERIMENTAL

Escitalopram combined with rTMS

Intervention Type: OTHER

The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Medication combined with sham physical therapy group

Medication combined with sham robotic navigational repetitive transcranial magnetic stimulation

Group Type: SHAM_COMPARATOR

Escitalopram combined with sham rTMS

Intervention Type: DRUG

The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Interventions

Escitalopram

The US Food and Drug Administration(FDA) has only approved fluoxetine and escitalopram for the treatment of adolescent depression

Intervention Type: DRUG

Interpersonal Psychotherapy for Adolescent

Interpersonal Psychotherapy for Adolescent(IPT-A), A modified version of interpersonal psychotherapy, is shorter than the standard therapy duration (12-16 sessions), with a total of eight sessions, retaining the structure of the standard IPT but employing a series of strategies to extract the most important components to speed up the time process.

Intervention Type: OTHER

Escitalopram combined with psychotherapy

The subjects received adolescent interpersonal psychotherapy for adolescent(IPT-A) while taking medication

Intervention Type: OTHER

Escitalopram combined with rTMS

The subjects received Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Intervention Type: OTHER

Escitalopram combined with sham rTMS

The subjects received sham Robotic navigational repetitive transcranial magnetic stimulation while taking medication

Intervention Type: DRUG

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huang, Manli, M.D

Role: CONTACT

huangmanli@zju.edu.cn

13957162975 ext. 86

Facility Contacts

Huang Manli

Role: primary

huangmanli@zju.edu.cn

13957162975

Other Identifiers

IIT2023510

Identifier Type: -

Identifier Source: org_study_id