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Clinical efficacy and mechanism study of iTBS combined with medication in the treatment of adolescent depression disorder

Clinical efficacy and mechanism study of iTBS combined with medication in the treatment of adolescent depression disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120127
Enrollment
Unknown
Registered
2026-03-10
Start date
2025-04-05
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

depression

Interventions

iTBS treatment group:intermittent theta burst stimulation + Drug
Control group:Pseudo-stimulation + Drug

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
10 Years to 19 Years

Inclusion criteria

Inclusion criteria: 1. Age 10 to 19 years, of any gender. 2. Meets the DSM-5 diagnostic criteria for major depressive disorder and is currently in an episode. 3. First Beck Depression Inventory-II (BDI-II) total score >= 20 points. 4. Overall health is determined to be good based on medical history. 5. The patient voluntarily participates and has obtained consent from a guardian to participate in this study, signing the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Meets DSM-5 diagnostic criteria for psychiatric disorders such as psychotic disorders, manic episodes, autism spectrum disorder, intellectual disability, tic disorders, substance abuse, etc. 2. Presence of severe organic brain disease. 3. History of febrile seizures or epilepsy. 4. Clear suicidal thoughts, attempts, or behaviors within the past month. 5. Presence of metal implants in the head or skull, pacemaker, or cochlear implant. 6. Previous rTMS treatment with no response to an adequate course (i.e., at least 8 sessions of electroconvulsive therapy). 7. Positive urine toxicology screen, positive urine pregnancy test (for females only).

Design outcomes

Primary

MeasureTime frame
BDI-II score;

Secondary

MeasureTime frame
remission rate;Effective Rate;Number of adverse events and incidence rate;

Countries

China

Contacts

Public ContactYi Huang

West China Hospital of Sichuan University

huangyu@scu.edu.cn+86 28 85422114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026