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

ConditionDepression - Major Depressive Disorder
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorFirst Affiliated Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Experimental target a-iTBS treatment groupExperimental treatment 1 intervention
Group B: Conventional target a-iTBS treatment groupExperimental treatment 1 intervention
Group C: Sham stimulation treatment groupSham comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

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

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.

Time frame
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
2

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

Improvement in anxiety (SCARED minus the scores). The SCARED scale ranges from 0 to 82, with higher scores indicating worse anxiety symptoms.

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

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

The severity of the suicide risk. The C-SSRS scale ranges from 0 to 5, with higher scores indicating worse suicide risk severity.

Time frame
Baseline of treatment period, 10 days; The follow-up period was 1 month, 3 months
4

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

Improvement in sleep status (PSQI minus the scores). The PSQI scale ranges from 0 to 21, with higher scores indicating worse sleep quality.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

First Affiliated Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov

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