aiTBS for NSSI and Suicide in Adolescent Depression
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Non Suicidal Self Injury, Suicidal Ideation, Suicide and Self-harm
In brief
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.
Key facts
- Study ID
- NCT06210100
- Run by
- Central South University
- People needed
- 60
- Starts
- 2024-01-18
- Expected to finish
- 2025-02-01
- Last updated by the study team
- 2024-08-16
Who can join
Age: 12 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- The Second People's Hospital of Dali Bai Autonomous Prefecture — Dali, Yunnan, China (enrolling)
- Mental Health Institute of Second Xiangya Hospital — Changsha, China
Full record on ClinicalTrials.gov
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