Clinical trial NCT06061653: Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression
Official title: Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

1. Exclusion criteria for tDCS: (1) Patients with metal implants in the body; those with metal implants such as titanium or magnetic devices (including aneurysm clips); (2) Patients with implanted devices such as cardiac pacemakers, deep brain stimulators (DBS); (3) Patients with intracranial hypertension, skull defects, or tumors; (4) Patients with unstable vital signs such as severe cardiac or somatic diseases; (5) Patients in the acute phase of cerebrovascular diseases; (6) Patients with adverse reactions to electrical stimulation; (7) Patients with pain sensitivity, injury, or inflammation in the stimulation area.
2. Exclusion criteria for MRI;
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.

Primary outcomes:
measure: 24-item Hamilton Depression Rating Scale
timeFrame: Baseline
measure: 24-item Hamilton Depression Rating Scale
timeFrame: 1-month
measure: 24-item Hamilton Depression Rating Scale
timeFrame: 2-month
measure: 24-item Hamilton Depression Rating Scale
timeFrame: 3-month
measure: Child Depression Rating Scale-Revised
timeFrame: Baseline
measure: Child Depression Rating Scale-Revised
timeFrame: 1-month
measure: Child Depression Rating Scale-Revised
timeFrame: 2-month
measure: Child Depression Rating Scale-Revised
timeFrame: 3-month
Secondary outcomes:
measure: 17-item Hamilton Anxiety Rating Scale
timeFrame: Baseline
measure: 17-item Hamilton Anxiety Rating Scale
timeFrame: 1-month
measure: 17-item Hamilton Anxiety Rating Scale
timeFrame: 2-month
measure: 17-item Hamilton Anxiety Rating Scale
timeFrame: 3-month
measure: Beck Scale for Suicide Ideation
timeFrame: Baseline
measure: Beck Scale for Suicide Ideation
timeFrame: 1-month
measure: Beck Scale for Suicide Ideation
timeFrame: 2-month
measure: Beck Scale for Suicide Ideation
timeFrame: 3-month
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: Baseline
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 1-month
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 2-month
measure: the Chinese version of the Snaith-Hamilton Pleasure Scale
timeFrame: 3-month
measure: Interpersonal Relationship Scale
timeFrame: Baseline
measure: Interpersonal Relationship Scale
timeFrame: 1-month
measure: Interpersonal Relationship Scale
timeFrame: 2-month
measure: Interpersonal Relationship Scale
timeFrame: 3-month
measure: Emotion Regulation Questionnaire
timeFrame: Baseline
measure: Emotion Regulation Questionnaire
timeFrame: 1-month
measure: Emotion Regulation Questionnaire
timeFrame: 2-month
measure: Emotion Regulation Questionnaire
timeFrame: 3-month
measure: Toronto Alexithymia Scale-20
timeFrame: Baseline
measure: Toronto Alexithymia Scale-20
timeFrame: 1-month
measure: Toronto Alexithymia Scale-20
timeFrame: 2-month
measure: Toronto Alexithymia Scale-20
timeFrame: 3-month
measure: The Reflective Function Questionnaire for Youths
timeFrame: Baseline
measure: The Reflective Function Questionnaire for Youths
timeFrame: 1-month
measure: The Reflective Function Questionnaire for Youths
timeFrame: 2-month
measure: The Reflective Function Questionnaire for Youths
timeFrame: 3-month
measure: Comfort Rating Questionnaire
timeFrame: Baseline
measure: Comfort Rating Questionnaire
timeFrame: 1-month
measure: Comfort Rating Questionnaire
timeFrame: 2-month
measure: Comfort Rating Questionnaire
timeFrame: 3-month
measure: IL-6 level
timeFrame: Baseline
measure: IL-6 level
timeFrame: 2-month
measure: MRI data
timeFrame: Baseline
measure: MRI data
timeFrame: 2-month
measure: EEG data
timeFrame: Baseline
measure: EEG data
timeFrame: 2-month
measure: TMS-evoked potentials(TEPs)
timeFrame: Baseline
measure: TMS-evoked potentials(TEPs)
timeFrame: 2-month
measure: Thinc-integrated Tools(THINC-it)
timeFrame: Baseline
measure: Thinc-integrated Tools(THINC-it)
timeFrame: 2-month
measure: Perceptual judgment test
timeFrame: Baseline
measure: Perceptual judgment test
timeFrame: 2-month
measure: Distance memory test
timeFrame: Baseline
measure: Distance memory test
timeFrame: 2-month
measure: ERP experiment
timeFrame: Baseline
measure: ERP experiment
timeFrame: 2-month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References: