Actively Recruiting
aiTBS for NSSI and Suicide in Adolescent Depression
Led by Central South University · Updated on 2024-08-16
60
Participants Needed
2
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
aiTBS for NSSI and Suicide in Adolescent Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the DSM-5 diagnostic criteria for major depressive disorder
- Aged 12 to 18 years with at least one guardian to monitor them for 3 months
- Hamilton Depression Rating Scale (HAMD-17) total score of 18 or higher
- Hospitalized with two or more non-suicidal self-injury behaviors in the week before admission
- Non-suicidal self-injury behavior on more than 5 days in the past year
- Baseline Deliberate Self-Harm Inventory (DSHI) score of 2 or higher
- Informed consent obtained from patient and guardian
You will not qualify if you...
- Substance abuse of psychoactive drugs or alcohol
- Severe physical disability preventing follow-up
- Other major mental illnesses meeting DSM-5 criteria (e.g., bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, ADHD)
- Severe physical, neurological disease, or traumatic brain injury affecting brain structure or function
- Unable to read, understand, complete assessments, or cooperate with investigators
- Implanted pacemaker, metal, or magnetic objects in the body or other conditions unsuitable for rTMS
- History or family history of epilepsy or other contraindications to TMS
- Daily use of benzodiazepines (>2mg/day), theophylline, stimulants, anticonvulsants
- Received systematic psychotherapy or TMS within 3 months before baseline
- Other examination abnormalities deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China, 671014
Actively Recruiting
2
Mental Health Institute of Second Xiangya Hospital
Changsha, China, 410001
Not Yet Recruiting
Research Team
J
Jun Yang, M.D.
CONTACT
J
Jing Huang, M.D. Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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