NCT06210100 aiTBS for NSSI and Suicide in Adolescent Depression
| NCT ID | NCT06210100 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central South University |
| Condition | Non Suicidal Self Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-01-18 |
| Primary Completion | 2024-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-01-18 with a primary completion date of 2024-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06210100 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Non Suicidal Self Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06210100 currently recruiting?
Yes, NCT06210100 is actively recruiting participants. Contact the research team at 724397007@qq.com for enrollment information.
Where is the NCT06210100 trial being conducted?
This trial is being conducted at Dali, China, Changsha, China.
Who is sponsoring the NCT06210100 clinical trial?
NCT06210100 is sponsored by Central South University. The trial plans to enroll 60 participants.