Status:
RECRUITING
aiTBS for NSSI and Suicide in Adolescent Depression
Lead Sponsor:
Central South University
Conditions:
Non Suicidal Self Injury
Suicidal Ideation
Eligibility:
All Genders
12-18 years
Phase:
NA
Brief 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 sui...
Detailed Description
The study will evaluate the efficacy and safety of aiTBS in depressive patients with NSSI or suicidal thoughts and behaviors by measuring changes in clinical ratings at baseline, after all the treatme...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06210100
Start Date
January 18 2024
End Date
February 1 2025
Last Update
August 16 2024
Active Locations (2)
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1
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China, 671014
2
Mental Health Institute of Second Xiangya Hospital
Changsha, China, 410001