Depression - Major Depressive Disorder
Conditions
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.
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.
Interventions
DEVICEExperimental 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.
DEVICEConventional 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.
Participants will receive a sham stimulation treatment designed to simulate the a-iTBS procedure without generating an effective magnetic field output.
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
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 -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CDRS-R (Children's Depression Rating Scale) scores from baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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 | Improvement in anxiety (SCARED minus the scores). The SCARED scale ranges from 0 to 82, with higher scores indicating worse anxiety symptoms. |
| 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 | The severity of the suicide risk. The C-SSRS scale ranges from 0 to 5, with higher scores indicating worse suicide risk severity. |
| 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 | Improvement in sleep status (PSQI minus the scores). The PSQI scale ranges from 0 to 21, with higher scores indicating worse sleep quality. |
| 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 | 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. |
| Change in CGI-S (Clinical Global Impressions-Severity Scales) scores from baseline | 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. |
| Change in CGI-I (Clinical Global Impressions-Improvement Scales) scores from baseline | 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). |
| Change in RSS (Ruminative Responses Scale) | 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. |
Countries
China
Contacts
CONTACTXinyu Zhou
Outcome results
None listed