About this trial
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) intervention for adolescent depression through a pilot clinical trial. The findings will inform the design and optimization of subsequent formal randomized controlled trials, providing essential evidence for their execution.
Eligibility criteria
Qualifiers
Age 12 - 18
Diagnosis of major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed through the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime version (K-SADS-PL), currently in a depressive episode
Score≥40 on the CDRS-R
Stable pharmacological treatment: At least 4 weeks of stable psychiatric medication use prior to enrollment, with continuation of the same psychiatric medication regimen throughout the study.
Disqualifiers
Psychiatric comorbidities other than anxiety disorders
Depression with psychotic symptoms
Young Mania Rating Scale (YMRS) score >13
A history of neurological disorders (e.g., epilepsy, brain injury) or severe somatic diseases (e.g., thyroid disorders, lupus, diabetes, pulmonary, hepatic, or renal impairment, major trauma)
Trial design
Treatments tested in this trial
- Experimental target rTMS treatment
- Conventional target rTMS treatment
- Sham stimulation treatment
Treatment groups
Locations
1Sponsors and collaborators
First Affiliated Hospital of Chongqing Medical University
Lead sponsor