Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder
Starting soon · Not applicable · Has a placebo group
Conditions studied: Depression - Major Depressive Disorder
In brief
This study aims to assess the feasibility, safety, acceptability, and preliminary efficacy trends of a Accelerated Intermittent Theta-burst Stimulation (a-iTBS) 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.
Key facts
- Study ID
- NCT07369713
- Run by
- First Affiliated Hospital of Chongqing Medical University
- People needed
- 45
- Starts
- 2026-08-01
- Expected to finish
- 2028-08-01
- Last updated by the study team
- 2026-03-04
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- (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.
You may not qualify if…
- Psychiatric comorbidities other than anxiety disorders
- Depression with psychotic symptoms
- Young Mania Rating Scale (YMRS) score >13
- 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)
- Patients currently using anticonvulsants or high-dose benzodiazepines
- A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
- A history of alcohol or substance abuse or dependence
- Women who are pregnant or breastfeeding
- Current high suicide risk
- Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
- Contraindications to MRI -
Where it is running
- The First Affiliated Hospital of Chongqing Medical University — Chongqing, China
Full record on ClinicalTrials.gov
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