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Target-Guided Intermittent Theta-Burst Stimulation for Adolescent Treatment-Resistant Depression: Efficacy and Neural Mechanisms

Target-Guided Intermittent Theta-Burst Stimulation for Adolescent Treatment-Resistant Depression: Efficacy and Neural Mechanisms

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600116527
Enrollment
Unknown
Registered
2026-01-12
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Group 1:The Group1 first received individualized target real stimulation based on functional connectivity, followed by individualized target sham stimulation based on functional connectivity.
Group 2:The Group2 first received individualized target sham stimulation based on functional connectivity, followed by individualized target real stimulation based on functional connectivity.

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Age 12–17 years (inclusive). 2. Meets DSM-5 criteria for major depressive disorder (MDD) on the Chinese version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children—Present and Lifetime Version (K-SADS-PL-C/DSM-5). 3. HAMD-24 total score >= 20 and MSM score >= 7 (moderate-to-severe treatment resistance). 4. No serious medical conditions (e.g., cardiac, hepatic, or renal insufficiency) or neurological disorders (e.g., stroke, neurodegenerative disease) and able to cooperate with iTBS. 5. No changes in dosage or type of primary antidepressants (e.g., SSRIs, SNRIs) or other psychotropic medications (e.g., aripiprazole, quetiapine) within the 2 weeks before enrollment; medications must remain stable throughout the study and follow-up, although short-term benzodiazepines may be prescribed as clinically indicated. 6. No physical treatments—including but not limited to electroconvulsive therapy, rTMS, or transcranial direct-current stimulation—within 1 month before enrollment.

Exclusion criteria

Exclusion criteria: 1. Any psychiatric disorder other than generalized anxiety disorder or attention-deficit/hyperactivity disorder (ADHD) according to K-SADS-PL-DSM (e.g., schizophrenia). 2. Current manic or hypomanic episode, with a Young Mania Rating Scale (YMRS) score > 5. 3. Serious or unstable medical conditions (e.g., epilepsy, cerebral contusion/laceration, intracranial surgery, malignant tumor, autoimmune disease, uncontrolled hypertension). 4. Metallic implants (e.g., aneurysm clips, deep-brain stimulation electrodes) or other implanted medical devices. 5. Pregnancy or breastfeeding. 6. Any factor judged by the investigator to interfere with study results or increase participant risk (e.g., poor compliance, high suicide risk).

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale score;

Secondary

MeasureTime frame
Children's Depression Inventory score;Beck Scale for Suicide Ideation score;Adolescent Non-Suicidal Self-Injury Assessment Questionnaire score;Pittsburgh Sleep Quality Index score;Cognitive assessment;Brain structure, function, and neural networks;EEG power and microstate parameters;

Countries

China

Contacts

Public ContactQingjiu Cao

Peking University Sixth Hospital

caoqingjiu@bjmu.edu.cn+86 10 8280 1939

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026