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

March 2, 2026 updated by: Xinyu Zhou, First Affiliated Hospital of Chongqing Medical University

Efficacy and Safety of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) in Adolescents With Depressive Disorder: A Randomized, Double-Blind, Controlled Pilot Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized, double-blind, controlled pilot trial aimed at evaluating the feasibility, safety, acceptability, and preliminary efficacy trends of Accelerated Intermittent Theta-burst Stimulation (a-iTBS) for the treatment of adolescent depression.

Adolescents diagnosed with Major Depressive Disorder (MDD) will be randomly assigned in a 1:1:1 ratio to one of three groups: the experimental target a-iTBS treatment group, the conventional target a-iTBS treatment group, and the sham stimulation group. All three groups will receive 10 consecutive days of a-iTBS stimulation (5 Hz, 90% RMT) or sham stimulation intervention, using the Blackdolphin TMS Robot (SLD-YXRJ) by Xi'an Solide Brain Modulation Ltd. Co., with 50 sessions in total. The intervention frequency and procedure will remain consistent across all groups.

In the experimental target a-iTBS treatment group, participants will undergo MRI-guided identification of the left dorsolateral prefrontal cortex (DLPFC) region, where the voxel most negatively correlated with the functional connectivity of the subgenual anterior cingulate cortex (sgACC) will serve as the stimulation target. In the conventional target a-iTBS treatment group, participants will have the standard F3 target in the DLPFC identified via MRI guidance as the stimulation site. Participants in the sham stimulation group will receive a placebo treatment, simulating the a-iTBS procedure without generating an effective magnetic field output.

The primary outcome of the treatment phase is the efficacy rate or the remission rate of depressive symptoms. Secondary outcomes include symptom scales, anxiety symptoms, suicide risk, quality of life, sleep, rumination, and cognition. Safety will be monitored through adverse events, vital signs, laboratory tests, and tolerability assessments.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Chongqing, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

(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.

-

Exclusion Criteria:

  1. Psychiatric comorbidities other than anxiety disorders
  2. Depression with psychotic symptoms
  3. Young Mania Rating Scale (YMRS) score >13
  4. 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)
  5. Patients currently using anticonvulsants or high-dose benzodiazepines
  6. A history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), transcranial direct current stimulation (tDCS), transcranial alternating current stimulation (tACS), or other neuromodulation treatments
  7. A history of alcohol or substance abuse or dependence
  8. Women who are pregnant or breastfeeding
  9. Current high suicide risk
  10. Potential complicating factors related to transcranial magnetic stimulation, such as scalp conditions or perforations that may affect magnetic field delivery
  11. Contraindications to MRI -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental target a-iTBS treatment group
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
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: Conventional target a-iTBS treatment group
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
Participants will undergo MRI-guided identification of the standard F3 target in the dorsolateral prefrontal cortex (DLPFC) as the stimulation site.
Sham Comparator: Sham stimulation treatment group
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
Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in CDRS-R (Children's Depression Rating Scale) scores from baseline
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BDI-II (Baker Depression Scale) scores from baseline
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

Change in Beck Depression Inventory - Second Edition (BDI-II) scores from baseline.

The BDI-II scale ranges from 0 to 63, with higher scores indicating worse depressive symptoms.
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
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Improvement in anxiety (SCARED minus the scores). The SCARED scale ranges from 0 to 82, with higher scores indicating worse anxiety symptoms.
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)
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
The severity of the suicide risk. The C-SSRS scale ranges from 0 to 5, with higher scores indicating worse suicide risk severity.
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
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Improvement in sleep status (PSQI minus the scores). The PSQI scale ranges from 0 to 21, with higher scores indicating worse sleep quality.
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
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Improvement of children's quality of life (PedsQL 4.0 minus the scores). The PedsQL 4.0 scale ranges from 0 to 100, with higher scores indicating better quality of life.
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

Improvement in overall clinical impression severity (7-point scale, with 1 being normal and 7 being among the most severely impaired).

The CGI-S scale ranges from 1 to 7, with higher scores indicating worse clinical severity.
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Improvement of clinical general impression (7-point scale, with 1 denoting very much improved and 7 denoting very much worse, with higher scores indicating worse clinical improvement).
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
Change in RSS (Ruminative Responses Scale)
Time Frame: Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
The level of improvement in negative thinking. The RSS scale ranges from 0 to 4 for each item, with a total possible score of 0 to 36, with higher scores indicating worse ruminative thinking.
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

August 1, 2027

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 18, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1stChongqingCQMU___ZXYa-iTBS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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