Using aiTBS to treat self-injury and suicidal thoughts in depressed adolescents

Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression

This study is testing if a new brain treatment called aiTBS can help teenagers with depression who self-harm or have thoughts of suicide feel better compared to those who receive a placebo treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Central South University (other)
• Locations: 2 sites (Dali, Yunnan and 1 other locations)
• Trial ID: NCT06210100 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of accelerated intermittent theta burst stimulation (aiTBS) using repetitive transcranial magnetic stimulation (rTMS) in adolescents aged 12-18 with major depressive disorder who exhibit non-suicidal self-injury (NSSI) or suicidal ideation. The study will randomly assign 60 hospitalized patients to receive either active aiTBS or a placebo sham treatment, with assessments conducted at baseline, after treatment, and at 4 and 8 weeks post-treatment. Various clinical scales will be used to measure changes in mood, self-injury behaviors, and overall functioning. The aim is to determine if aiTBS can significantly reduce NSSI and suicidal thoughts compared to a control group.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12-18 diagnosed with major depressive disorder and exhibiting non-suicidal self-injury behaviors.

Not a fit: Patients with severe comorbid mental illnesses or substance abuse issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new, effective intervention for adolescents struggling with self-injury and suicidal thoughts.

How similar studies have performed: Previous studies have shown promise in using rTMS for treatment-resistant depression, but the specific application of aiTBS for NSSI and suicidal ideation in adolescents is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
2. Patients aged 12-18 years with at least one guardian to monitor them for 3 months
3. HAMD-17 Total score ≥18
4. Hospitalized patients who had two or more non-suicidal self-injury behaviors meeting the DSM-5 diagnostic criteria in the week before admission (NSSI behavior of more than 5 days in the past year, and a baseline DSHI score ≥2 )
5. Obtain informed consent from patients and guardians

Exclusion Criteria:

1. Substance abusers such as psychoactive drugs or alcohol.
2. Severe physical disability and unable to complete follow-up.
3. Comorbid other major mental illnesses that meet the DSM-5 criteria, such as bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
4. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
5. Unable to read, understand and complete the assessment or to cooperate with the investigators.
6. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
7. A history or family history of epilepsy and other contraindications to TMS.
8. Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, etc.
9. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
10. Other examination abnormalities considered to be inappropriate by investigators.

Where this trial is running

Dali, Yunnan and 1 other locations

• The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali, Yunnan, China (RECRUITING)
• Mental Health Institute of Second Xiangya Hospital — Changsha, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Jun Yang, M.D.

Conditions: Non Suicidal Self Injury, Suicidal Ideation, Suicide and Self-harm, NSSI, MDD, TMS