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Recruiting NCT05384405

aiTBS for Relieving NSSI in Depressive Patients

Trial Parameters

Condition Major Depressive Disorder
Sponsor Central South University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 12 Years
Max Age 18 Years
Start Date 2022-07-01
Completion 2025-02-28
Interventions
Active iTBSSham iTBS

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 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) in patients with unipolar disorder and bipolar disorder.

Eligibility Criteria

Inclusion Criteria: 1. Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry. 2. Ages between 12 and 18 years 3. At least 1 caregivers to supervise the patient within 3 month. 4. A score of greater than 17 on the HAM-D17. 5. Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month. 6. Willingness to participate in the study and sign informed consents 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 schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc. 4. Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features. 5. Suffering from any severe physical disease, neurological

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