Feasibility, Safety, and Preliminary Clinical Efficacy of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Depression - Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT07185438

Run by

First Affiliated Hospital of Chongqing Medical University

People needed

45

Starts

2025-09-15

Expected to finish

2027-12-30

Last updated by the study team

2026-05-26

Who can join

Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (enrolling)

Full record on ClinicalTrials.gov

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