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NCT07873060
Comparing 10 Hz rTMS and iTBS for Adolescent Depression
Conditions: Depressive Disorder, Major Depressive Disorder, Adolescence
Sex: All
Ages: 11 Years – 19 Years
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: Qilu Hospital of Shandong University
Location: Shandong Mental Health Center Jinan Shandong
Summary
This trial compares two transcranial magnetic stimulation (TMS) protocols-10 Hz rTMS and intermittent theta burst stimulation (iTBS)-in adolescents with major depressive disorder. Eighty participants aged 11-19 years will be randomly assigned to receive either 10 Hz rTMS or iTBS over a two-week period. Clinical symptoms, cognitive function, brain imaging, and neurophysiological measures will be assessed at baseline, immediately post-treatment, and at a 1-month follow-up to evaluate both the immediate and sustained therapeutic effects and underlying mechanisms.
Eligibility Criteria
\*\*Inclusion Criteria:\*\*
* Aged 11 to 19 years
* Meeting the DSM-5 criteria for MDD
* Absence of current or past psychotic symptoms (e.g., auditory or visual hallucinations)
* No comorbid schizophrenia, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, panic disorder, or other severe psychiatric conditions
* No contraindications to MRI or TMS, including implanted cardiac pacemakers, neurostimulators, artificial metal heart valves, intracranial aneurysm clips, cochlear implants, or other metallic implants
\*\*Exclusion Criteria:\*\*
* Alcohol or substance dependence
* Severe or unstable medical conditions, including neurological, endocrine, and rheumatic diseases, brain disorders, traumatic brain injury or surgery, and infectious diseases
* Recent receipt of rTMS or electroconvulsive therapy
* High suicide risk
* A history of epilepsy or unprovoked seizures
* Pregnancy
Source: ClinicalTrials.gov (NCT07873060). StuddyBuddy aggregates publicly available trial information.