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 · NCT07185438 · Interventional (participants receive a specific treatment) · Lead sponsor: First Affiliated Hospital of Chongqing Medical University
View the official record on ClinicalTrials.gov →Interventions studied
Conventional target rTMS treatmentExperimental target rTMS treatmentSham stimulation treatment
What this trial is about
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.
Who can take part
Age range
12 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
1 location listed.
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, China