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The antidepressant efficacy and neural mechanism of theta burst stimulation in adolescent depression

The antidepressant efficacy and neural mechanism of theta burst stimulation in adolescent depression

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200060490
Enrollment
Unknown
Registered
2022-06-03
Start date
2022-10-01
Completion date
Unknown
Last updated
2024-05-21

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

Conditions

adolescent depression

Interventions

drug-naive iTBS+cTBS group:Intermittent ? Burst Stimulation (iTBS) + Persistent ? Burst Stimulation (cTBS)
drug-naive iTBS group:iTBS
drug-naive sham group:Pseudo-stimulus
treatment-resistant depression iTBS+cTBS group:iTBS+cTBS
treatment-resistant depression iTBS group:iTBS
treatment-resistant depression sham group:Pseudo-stimulus

Sponsors

Affiliated Brain Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Aged 12-18 years; 2. Diagnosed with major depressive disorder by screening SCID-5 and DSM-5; 3. HAMD-17 score >= 17; 4. Drug-naive cohort: meeting psychopharmacological drug-naive; treatment-resistant depression: meeting the definition of treatment-resistant depression: at least one category of antidepressants was used in sufficient amounts in treatment course and they reported a poor therapeutic effect; 5. Both the subjects and their guardians sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or claustrophobic; 2. History of organic brain disease, brain trauma or surgery; 3. Patients with major physical diseases such as heart, liver and kidney cannot tolerate this study; 4. Received MECT treatment within three months; 5. Previous history of seizures; 6. Contraindications for MRI examination; 7. There are contraindications to TMS therapy.

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Rating Scale 17 item version (HDRS-17);

Secondary

MeasureTime frame
Magnetic Resonance Imaging;Montgomery-Asberg Depression Rating Scale (MADRS);Hamilton Anxiety Scale;Columbia Suicide Severity Rating Scale, C-SSRS;Revised Non-suicidal NSSI Questionnaire Based on Ottawa NSSI Questionnaire;The Beck Hopelessness Scale;The 14-item McIntyre and Rosenblat Rapid Response Scale;McGill Pain Questionnaire Short-Form;Cognitive function;Snaith-Hamilton Pleasure Scale;Electroencephalogram;Global Assessment Function, GAF;rTMS Adverse Event Rating Scale;

Countries

China

Contacts

Public ContactZhou Yanling
zhouylivy@aliyun.com+86 20 81268211

Outcome results

None listed

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