Efficacy and Safety of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
First Affiliated Hospital of Chongqing Medical University
45 participants
Sep 15, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria4
- 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.
Exclusion Criteria11
- 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)
- Patients currently using anticonvulsants or high-dose benzodiazepines
- A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
- A history of alcohol or substance abuse or dependence
- Women who are pregnant or breastfeeding
- Current high suicide risk
- Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
- Contraindications to MRI
Interventions
Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.
participants will receive MRI-guided stimulation at the left DLPFC location.
Participants will receive a sham stimulation treatment designed to simulate the rTMS procedure without generating an effective magnetic field output.
Locations(1)
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NCT07185438