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A clinical randomized controlled study of a-iTBS with a pulse count of 90,000 for 5 sessions on 1 day versus 10 sessions on 1 day in the treatment of adolescent depression

A clinical randomized controlled study of a-iTBS with a pulse count of 90,000 for 5 sessions on 1 day versus 10 sessions on 1 day in the treatment of adolescent depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095668
Enrollment
Unknown
Registered
2025-01-10
Start date
2025-01-15
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Depressive disorders

Interventions

10-session 1800-pulse iTBS daily group:10 sessions of 1800 pulse iTBS per day, treated for 5 days
5-session 1800-pulse iTBS daily group:10 sessions of 1800 pulse iTBS per day, treated for 10 days

Sponsors

Affiliated Kangning Hospital of Ningbo University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1.age 12-18; 2.meet the diagnostic criteria for depression in the 10th Revision of the International Statistical Classification of Diseases (ICD-10); 3.total score of HAMD-17 >=17 points; 4.right-handed; 5.the patient's physical examination, medical history, vital signs, routine blood, urine and stool, liver and kidney function, electrolyte, electrocardiogram, electroencephalogram and other indicators were normaL; 6.after fully understanding the safety of transcranial magnetic stimulation (TMS), willing to actively cooperate with the treatment, and signed by the guardian and the informed consent;

Exclusion criteria

Exclusion criteria: 1.MECT treatment within 6 months prior to enrollment; 2.those with a history of severe physical illness and depression due to other psychoactive and non-dependent substances; 3.patients with metallic or electronic instruments placed in their bodies, such as intracranial metallic foreign bodies, cochlear implants, pacemakers and stents, and other metallic foreign bodies; 4.those at risk for seizures, with previous cranial disease, head trauma, alcoholism, EEG abnormalities, MRI evidence of structural abnormalities in the brain, or a family history of epilepsy,those with psychotic symptoms requiring a combination of antipsychotic medications; 5. Acute suicide; 6. Those who have psychotic symptoms and need to take antipsychotic drugs.

Design outcomes

Primary

MeasureTime frame
HAMD-17;

Secondary

MeasureTime frame
Neuropsychometric measures related to cognitive behaviour;anxiety symptom, suicidal ideation;Electrophysiology and blood oxygen indicators;

Countries

China

Contacts

Public ContactXiaoli Liu

Affiliated Kangning Hospital of Ningbo University

1206207800@qq.com+86 574 26302510

Outcome results

None listed

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