aiTBS for NSSI and Suicide in Adolescent Depression

Launched by CENTRAL SOUTH UNIVERSITY · Jan 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called accelerated intermittent theta burst stimulation (aiTBS), a type of brain stimulation, to see if it can help teenagers aged 12 to 18 with major depressive disorder who struggle with self-harm and suicidal thoughts. Researchers want to find out if this active treatment is more effective than a placebo, which is a treatment that looks like the real thing but doesn't actually work. This is important because many young people experience severe depression and may hurt themselves or think about suicide, and better treatment options are needed.

To participate in this trial, young people must be diagnosed with major depressive disorder and have had recent episodes of self-harm. They need to have a guardian who can help monitor their progress for three months. Unfortunately, those with certain other mental health conditions, serious medical issues, or specific medications may not be eligible. Participants will receive either the active treatment or placebo and will be monitored closely throughout the study. This trial aims to provide valuable information that could lead to better treatments for adolescents facing these challenging issues.

Gender

ALL

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.