Status:
NOT_YET_RECRUITING
Efficacy and Safety of Magnetic Resonance Imaging-guided Repetitive Transcranial Magnetic Stimulation (rTMS) in Adolescents With Depression: A Randomized, Double-Blind, Controlled Pilot Study
Lead Sponsor:
First Affiliated Hospital of Chongqing Medical University
Conditions:
Depression - Major Depressive Disorder
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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) interventio...
Detailed Description
This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Magnetic Resonance Imaging-guided Repeti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2026
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07185438
Start Date
September 15 2025
End Date
September 15 2026
Last Update
September 22 2025
Active Locations (1)
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1
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China