NCT07185438 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
| NCT ID | NCT07185438 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Chongqing Medical University |
| Condition | Depression - Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 45 participants in total. It began in 2025-09-15 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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) 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07185438 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Depression - Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07185438 currently recruiting?
Yes, NCT07185438 is actively recruiting participants. Contact the research team at zhouxinyu@cqmu.edu.cn for enrollment information.
Where is the NCT07185438 trial being conducted?
This trial is being conducted at Chongqing, China.
Who is sponsoring the NCT07185438 clinical trial?
NCT07185438 is sponsored by First Affiliated Hospital of Chongqing Medical University. The trial plans to enroll 45 participants.
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