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Recruiting NCT07554755

NCT07554755 TIS for NSSI in Adolescent Depression

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Clinical Trial Summary
NCT ID NCT07554755
Status Recruiting
Phase
Sponsor The Second Hospital of Anhui Medical University
Condition Temporal Interference Stimulation
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2026-04-30
Primary Completion 2026-10-30

Trial Parameters

Condition Temporal Interference Stimulation
Sponsor The Second Hospital of Anhui Medical University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 12 Years
Max Age 22 Years
Start Date 2026-04-30
Completion 2026-10-30
Interventions
Active Temporal Interference Stimulation (TIS)Sham Temporal Interference Stimulation (TIS)

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Brief Summary

Temporal Interference Stimulation (TIS) has been successfully used to help patients with depression. However, its role in alleviating self injuries remained uncertain. This trial will compare the effectiveness of TIS to a placebo control on non-suicidal self injury (NSSI) in patients with major depressive disorder(MDD).

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 12-22 years with at least one guardian to monitor them for 3 months 3. HAMD-17 Total score ≥18 4. Patients who had two or more non-suicidal self-injury behaviors meeting the 5.DSM-5 diagnostic criteria in the 2 weeks before admission (NSSI behavior of more than 5 days in the past year) 6.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 struc

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