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Efficacy of intermittent theta-burst stimulation versus 10-Hz repetitive transcranial magnetic stimulation in adolescents with major depressive disorder: a randomized, controlled non-inferiority trial

Efficacy of intermittent theta-burst stimulation versus 10-Hz repetitive transcranial magnetic stimulation in adolescents with major depressive disorder: a randomized, controlled non-inferiority trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500112348
Enrollment
Unknown
Registered
2025-11-12
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Depressive disorder

Interventions

10Hz rTMS group :10Hz repetitive transcranial magnetic stimulation

Sponsors

The Affiliated Brain Hospital, Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 17 Years

Inclusion criteria

Inclusion criteria: 1. Meeting the diagnostic criteria for major depressive disorder (MDD) according to the DSM-V; 2. A total score of >=17 on the 17-item Hamilton Depression Rating Scale (HAMD-17); 3. Aged 13 to 17 years, with at least 6 years of formal education; 4. First episode of depression, with no prior systematic treatment with antidepressants or antipsychotics; 5. Han Chinese ethnicity and right-handed; 6. Comprehend the study procedures and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of severe physical or organic brain disorders, or traumatic brain injury; 2. History of physical treatments such as electroconvulsive therapy, repetitive transcranial magnetic stimulation, transcranial direct current stimulation, or transcranial alternating current stimulation (tACS) within the past 6 months; 3. History of substance, alcohol, or psychoactive substance abuse; 4. Presence of metal implants in the body, such as a cardiac pacemaker; 5. Prior to or during treatment, a score >1 on item 4 ("To what extent have you had active suicide ideation?") or item 5 ("To what extent have you had passive suicidal ideation, i.e., wished to die without actively doing anything?") of the Beck Scale for Suicide Ideation (SSI).

Design outcomes

Primary

MeasureTime frame
Antidepressant relief rate;

Secondary

MeasureTime frame
Side effect;Neurocognitive function; The concentrations of oxygenated hemoglobin;

Countries

China

Contacts

Public ContactZheng Wei

The Affiliated Brain Hospital, Guangzhou Medical University

zhengwei0702@163.com+86 20 8126 8028

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026