Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder

NCT07369713 | Not Yet Recruiting DMC

• 1 other identifier: 1stChongqingCQMU___ZXYa-iTBS
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression - Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Change in CDRS-R (Children's Depression Rating Scale) scores from baseline

  Response rate of depressive symptoms (defined as ≥50% reduction in CDRS-R score) or remission rate of depressive symptoms (defined as CDRS-R score ≤28). The CDRS-R scale ranges from 0 to 54, with higher scores indicating worse depressive symptoms.

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

Secondary Outcomes (8)

• Change in BDI-II (Baker Depression Scale) scores from baseline

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

• Change in SCARED (The Screen for Child Anxiety-Related Emotional Disorders) scores from baseline

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

• Change in suicide risk from baseline on the C-SSRS (Columbia Suicide Severity Rating Scale)

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

• Change in PSQI (Pittsburgh Sleep Quality Index) scores from baseline

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

• Change in PedsQL4.0 (The Pediatric Quality of Life Inventory) scores from baseline

  Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

Study Arms (3)

Experimental target a-iTBS treatment group

EXPERIMENTAL

Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.

Device: Experimental target a-iTBS treatment

Conventional target a-iTBS treatment group

EXPERIMENTAL

Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site. Accelerated Intermittent Theta-burst Stimulation (a-iTBS) (5 Hz, 90% RMT) will be administered using the Blackdolphin TMS Robot device (model SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions over 10 consecutive days.

Device: Conventional target a-iTBS treatment

Sham stimulation treatment group

SHAM COMPARATOR

Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output. The intervention will use a dedicated sham stimulation coil, which is identical in appearance, operation, and stimulation protocol to the experimental group. This coil is designed to maintain the same auditory and tactile sensations as the active stimulation but is equipped with an electromagnetic shielding structure or an internal reverse coil arrangement to effectively prevent magnetic flux from penetrating the skull, ensuring no actual neuromodulatory effects.

Device: Sham stimulation treatment

Interventions

Conventional target a-iTBS treatment DEVICE

Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site.

Conventional target a-iTBS treatment group

Sham stimulation treatment DEVICE

Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.

Sham stimulation treatment group

Experimental target a-iTBS treatment DEVICE

Participants will undergo MRI-guided identification of the voxel in the left dorsolateral prefrontal cortex (DLPFC) that is most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) as the stimulation site.

Experimental target a-iTBS treatment group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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 -

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, 400016, China

Location

Central Study Contacts

Xinyu Zhou

CONTACT

15823996993; zhouxinyu@cqmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: This study employs a parallel assignment design. Participants will be randomly assigned in a 1:1:1 ratio to the experimental target a-iTBS treatment group, the conventional target a-iTBS treatment group, or the sham stimulation group. All three groups will utilize the Blackdolphin TMS Robot device (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., receiving 50 sessions of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation over 10 consecutive days, with consistent intervention frequency and procedures. Participants will remain in their assigned group for the entire study duration without any crossover.

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: January 27, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2028
• Last Updated: March 4, 2026

Record last verified: 2026-01

Locations

CN (1)