Using brain stimulation to help young people with mild depression

Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.

This study is testing if a type of brain stimulation can help young people aged 12-25 with mild depression feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 12 Years to 25 Years
• Sex: All
• Sponsor: Guangzhou Psychiatric Hospital (Government)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06294184 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate how transcranial direct current stimulation (tDCS) can alleviate subthreshold depressive symptoms in young individuals aged 12-25. Participants will be randomly assigned to receive either active tDCS targeting specific brain areas or a sham stimulation over 10 sessions in two weeks. Assessments will be conducted at baseline, after the stimulation period, and at follow-ups to measure changes in brain function, depressive symptoms, and emotional and social interactions. The study seeks to understand the mechanisms behind tDCS effects and predict individual outcomes.

Who should consider this trial

Good fit: Ideal candidates are right-handed individuals aged 12-25 with mild depressive symptoms lasting more than one week.

Not a fit: Patients with major depressive episodes or other specified psychiatric disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could provide a non-invasive treatment option for young individuals experiencing mild depressive symptoms.

How similar studies have performed: Previous studies have shown promise in using tDCS for treating depressive symptoms, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* 1\) Be between the ages of 12-25;
* 2\) is right-handed on the Edinburgh Handedness Inventory;
* 3\) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
* 4\) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, \< 24 points;
* 5\) Gender is not limited;
* 6\) Subjects and their families voluntarily participate and sign the informed consent form.

Exclusion Criteria:

* 1\) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
* 2\) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
* 3\) Severe or unstable physical illness;
* 4\) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
* 5\) Received transcranial direct current stimulation in the past three months (continuous intervention time: \>2 weeks);
* 6\) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
* 7\) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.

Where this trial is running

Guangzhou, Guangdong

• Guangzhou Brain hospital(Guangzhou Huiai Hospital) — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Robin Shao, Ph.D — The Affiliated Brain Hospital of Guangzhou Medical University
• Study coordinator: Kangguang Lin, M.D;Ph.D

Conditions Subthreshold Depression; Young People; Transcranial Direct Current Stimulation; Resting-state brain functional network; Social emotion