Combining Interpersonal Therapy with Brain Stimulation for Teen Depression

Effects of Augmentation of Interpersonal Psychotherapy With High-Definition Transcranial Direct Current Stimulation for Adolescent Depression: A Randomized Clinical Trial

This study is testing if adding brain stimulation to talk therapy can help teenagers with depression feel better compared to just talk therapy alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06061653 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of augmenting interpersonal psychotherapy (IPT) with high-definition transcranial direct current stimulation (HD-tDCS) in treating adolescent depression. It targets adolescents aged 12 to 18 who meet the DSM-5 criteria for depression and have either their first episode or a relapse of depression. Participants will be randomly assigned to receive either IPT with HD-tDCS or IPT with sham stimulation, allowing researchers to compare the outcomes of both approaches. The study aims to address the unique challenges of treating depression in adolescents, particularly given the limitations of current pharmacological options.

Who should consider this trial

Good fit: Ideal candidates for this study are right-handed adolescents aged 12 to 18 of Han ethnicity who are experiencing their first episode of depression or a relapse and have not received prior treatment.

Not a fit: Patients with metal implants, certain medical conditions, or those who have previously received treatment for depression may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for adolescents suffering from depression.

How similar studies have performed: While the combination of IPT and HD-tDCS is a novel approach, previous studies have shown promising results for both IPT and tDCS in treating depression.

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.

Where this trial is running

Hangzhou, Zhejiang

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Manli Huang, M.D

Conditions Depressive Disorder