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

NCT06061653 | Unknown

• 1 other identifier: IIT2023496
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (8)

• 24-item Hamilton Depression Rating Scale

  Assessment of depressive symptoms. Score\<8: normal; \>20: mild or moderate depression; \>35: severe depression.

  Baseline

• 24-item Hamilton Depression Rating Scale

  Assessment of depressive symptoms. Score\<8: normal; \>20: mild or moderate depression; \>35: severe depression.

  1-month

• 24-item Hamilton Depression Rating Scale

  Assessment of depressive symptoms. Score\<8: normal; \>20: mild or moderate depression; \>35: severe depression.

  2-month

• 24-item Hamilton Depression Rating Scale

  Assessment of depressive symptoms. Score\<8: normal; \>20: mild or moderate depression; \>35: severe depression.

  3-month

• Child Depression Rating Scale-Revised

  Assessment of depressive symptoms. Score\<40: normal; 40\~60: mild or moderate depression; \>60: severe depression.

  Baseline

• Child Depression Rating Scale-Revised

  Assessment of depressive symptoms. Score\<40: normal; 40\~60: mild or moderate depression; \>60: severe depression.

  1-month

• Child Depression Rating Scale-Revised

  Assessment of depressive symptoms. Score\<40: normal; 40\~60: mild or moderate depression; \>60: severe depression.

  2-month

• Child Depression Rating Scale-Revised

  Assessment of depressive symptoms. Score\<40: normal; 40\~60: mild or moderate depression; \>60: severe depression.

  3-month

Secondary Outcomes (48)

• 17-item Hamilton Anxiety Rating Scale

  Baseline

• 17-item Hamilton Anxiety Rating Scale

  1-month

• 17-item Hamilton Anxiety Rating Scale

  2-month

• 17-item Hamilton Anxiety Rating Scale

  3-month

• Beck Scale for Suicide Ideation

  Baseline

Study Arms (2)

IPT plus HD-tDCS

EXPERIMENTAL

Combination Product: IPT plus HD-tDCS

IPT plus sham HD-tDCS

SHAM COMPARATOR

Combination Product: IPT plus sham HD-tDCS

Interventions

IPT plus HD-tDCS COMBINATION_PRODUCT

psychotherapy plus device

IPT plus HD-tDCS

IPT plus sham HD-tDCS COMBINATION_PRODUCT

psychotherapy plus sham device

IPT plus sham HD-tDCS

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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);
• Age between 12 and 18 years;
• Right-handed;
• Han ethnicity;
• Meet the DSM-5 diagnostic criteria for depression;
• HAMD-24≥20;
• Understand written language and able to complete questionnaires;
• 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.

You may not qualify if:

• Patients with severe neurological, cardiac, liver, kidney, endocrine, and blood system diseases, or any other condition that may interfere with the study evaluation;
• Patients with organic mental disorders and mental retardation;
• Patients with alcohol or drug dependence;
• Patients with a high risk of suicide.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Depressive Disorder

Interventions

adenylate isopentenyltransferase

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Central Study Contacts

Manli Huang, M.D

CONTACT

13957162975; huangmanli@zju.edu.cn

Xiaoyi Zhou

CONTACT

15158866089; zhouxiaoyi@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 29, 2023
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-05

Locations

CN (1)