RecruitingNot ApplicableNCT06210100

aiTBS for NSSI and Suicide in Adolescent Depression

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

Sponsor

Central South University

Enrollment

60 participants

Start Date

Jan 18, 2024

Study Type

INTERVENTIONAL

Conditions

Suicidal Ideation Suicide and Self-harm Non Suicidal Self Injury

Summary

Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries with and without suicidal ideation remained uncertain. This trial will compare the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS to a placebo control on non-suicidal self injury (NSSI) and suicidal attempts in patients with major depressive disorder.

Eligibility

Min Age: 12 YearsMax Age: 18 Years

Inclusion Criteria5

Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
Patients aged 12-18 years with at least one guardian to monitor them for 3 months
HAMD-17 Total score ≥18
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 )
Obtain informed consent from patients and guardians

Exclusion Criteria10

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