Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression

NCT ID: NCT06061653

Last Updated: 2023-10-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2025-12-31

Brief Summary

Depression is among the most prevalent psychiatric disorders, with an upward trend in its manifestation in younger individuals. In contrast to adult depression, adolescent depression often presents with longer attack durations, higher recurrence rates, chronicity, and elevated disability rates. At present, treatment options for adolescent depression encompass pharmacological, physical, and psychological therapies. However, current evidence suggests that no antidepressant medication is entirely safe for youths, with only fluoxetine and escitalopram being FDA-approved for treating adolescent depression.

Given the weight of interpersonal stressors faced by teenagers, the NICE guidelines recommend interpersonal therapy(IPT) as a first-line treatment. A 2020 meta-analysis in the Journal of the American Academy of Child and Adolescent Psychiatry reported that interpersonal therapy exhibited significantly greater improvements in depression symptoms than cognitive behavioral therapy(CBT), although psychotherapeutic effects were modest, achieving a remission rate of 60%. These results underscore the need for further research to enhance interpersonal therapy's effectiveness in treating adolescent depression.

High-Definition Transcranial Direct Current Stimulation (HD-tDCS）is a highly secure non-invasive brain stimulation technique that produces sustained effects even after stimulation has discontinued, rendering it particularly valuable for therapeutic interventions. The proposed study aims to augment a single IPT treatment with HD-tDCS stimulation for adolescent depression. By enhancing the excitability of the cerebral cortex, HD-tDCS could potentially enhance IPT's therapeutic efficacy in treating adolescent depression while facilitating further investigation of its underlying neural circuit mechanisms.

Conditions

Depressive Disorder

Study Design

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

Study Groups

IPT plus HD-tDCS

Group Type: EXPERIMENTAL

IPT plus HD-tDCS

Intervention Type: COMBINATION_PRODUCT

psychotherapy plus device

IPT plus sham HD-tDCS

Group Type: SHAM_COMPARATOR

IPT plus sham HD-tDCS

Intervention Type: COMBINATION_PRODUCT

psychotherapy plus sham device

Interventions

IPT plus HD-tDCS

psychotherapy plus device

Intervention Type: COMBINATION_PRODUCT

IPT plus sham HD-tDCS

psychotherapy plus sham device

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

Inclusion Criteria

1. Sign a written informed consent form, willing to participate in the study and accept treatment (patients under 18 years of age need to obtain the consent of their parents or legal guardians);

2. Age between 12 and 18 years;

3. Right-handed;

4. Han ethnicity;

5. Meet the DSM-5 diagnostic criteria for depression;

6. HAMD-24≥20;

7. Understand written language and able to complete questionnaires;

8. First-episode depression patients who have never received any treatment or relapse depression patients, have not taken any psychotropic drugs in the past 2 weeks, have not received systematic psychological or physical therapy.

Exclusion Criteria

3. Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;

4. Patients with organic mental disorders and mental retardation;

5. Patients with alcohol or drug dependence;

6. Patients with a high risk of suicide.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

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

Manli Huang, M.D

Role: CONTACT

huangmanli@zju.edu.cn

13957162975 ext. 86

Xiaoyi Zhou

Role: CONTACT

zhouxiaoyi@zju.edu.cn

15158866089 ext. 86

Facility Contacts

Huang Manli

Role: primary

huangmanli@zju.edu.cn

13957162975

Other Identifiers

IIT2023496

Identifier Type: -

Identifier Source: org_study_id