MRI-guided rTMS for adolescents with major depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, controlled pilot assigns adolescents with DSM-5 major depressive disorder to one of three groups: MRI-guided experimental-target rTMS, conventional left DLPFC rTMS, or sham stimulation in a 1:1:1 ratio. All participants receive 20 weekday sessions over 4 weeks of 10 Hz stimulation at 120% resting motor threshold using a Blackdolphin TMS robot, with the experimental group targeting the voxel in the left DLPFC most negatively correlated with subgenual ACC connectivity. The trial measures feasibility, safety, acceptability, and preliminary trends in efficacy to inform the design of larger randomized trials. Participants must complete MRI scans and attend daily in-person stimulation sessions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 12 - 18
2. 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
3. Score≥40 on the CDRS-R
4. 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 Criteria:

1. Psychiatric comorbidities other than anxiety disorders
2. Depression with psychotic symptoms
3. Young Mania Rating Scale (YMRS) score \>13
4. 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)
5. Patients currently using anticonvulsants or high-dose benzodiazepines
6. A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
7. A history of alcohol or substance abuse or dependence
8. Women who are pregnant or breastfeeding
9. Current high suicide risk
10. Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
11. Contraindications to MRI

Where it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Xinyu Zhou
• Email: zhouxinyu@cqmu.edu.cn
• Phone: 15823996993

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.