aiTBS for NSSI and Suicide in Adolescent Depression (NCT06210100) | Clinical Trial Compass
RecruitingNot Applicable
aiTBS for NSSI and Suicide in Adolescent Depression
China60 participantsStarted 2024-01-18
Plain-language 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.
Who can participate
Age range12 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
Changes in the Deliberate Self-Harm Inventory (DSHI)
Timeframe: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment