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A randomized, double-blind, controlled study to explore the effects and mechanisms of repeated transcranial magnetic stimulation on NSSI behavior in adolescents with major depression

A randomized, double-blind, controlled study to explore the effects and mechanisms of repeated transcranial magnetic stimulation on NSSI behavior in adolescents with major depression

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087088
Enrollment
Unknown
Registered
2024-07-19
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non suicidal self injury

Interventions

rTMS treatment group:repetitive transcranial magnetic stimulation: 120% rest motor threshold
40 pulses over 4 s [10 Hz]
inter-train interval, 26 s
75 trains
3,000 pulses
five times a week for a total of four weeks.
rTMS pseudostimulus group:repeat transcranial magnetic pseudostimulation: The stimulation parameters of the dummy stimulus are the same as in active therapy, but the angle of the coil is 45 ° from the

Sponsors

The First Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 18 Years

Inclusion criteria

Inclusion criteria: A Patients who meet DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition) diagnostic criteria for major depressive disorder with single episode (296.2) or recurrent episode (296.3) without psychotic features; B Concise International Neuropsychiatric Interview 7.0.0 (M.I.N.1.7.0.0) confirmed that participants had a major depressive episode (MDD); C HAMD-17=24 points during screening and baseline; D Age 12-18 years old (including cut-off value), gender is not limited; E Currently on antidepressant therapy with one of fluoxetine, sertraline, fluvoxamine, etc.; F Subjects who understand and are willing to strictly adhere to the clinical trial protocol and sign the informed consent form;

Exclusion criteria

Exclusion criteria: A Previous diagnosis of the following diseases or associated medical history; Depression associated with organic mental disorders; clinically significant neurological disorders (including epilepsy, encephalopathy); Any neurodegenerative disease; Moderate or severe head trauma or other neurological disorders that may involve central nervous system function; B Currently have a diagnosis of other mental disorders other than depression that meet DSM-5 [schizophrenia spectrum and other psychotic disorders or bipolar and related disorders, anxiety disorders, obsessive-compulsive and related disorders, somatic symptoms and related disorders, substance-related and addictive disorders (except caffeine, nicotine), etc.]; C Hamilton Anxiety Scale (HAMA) = 14; D has a history of previous suicide attempts, or the patient is currently at significant risk of suicide as judged by the investigator, or HAMD17 item 3 (suicide) score > 3; E Pregnant and lactating women; F Other patients who are not suitable for rTMS treatment;

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale, HAMD-17;Adolescent Non-suicidal Self-injury Assessment Questionnaire;clinical global impression scal;Pittsburgh sleep quality index;The Wisconsin Card Sorting Test;Blood markers (amino-enkephalin, methionine-enkephalin, alpha-endorphin, brain-derived neurotrophic factor);

Secondary

MeasureTime frame
Hamilton Anxiety Scale, HAMA;Colombian Suicide Severity Rating Scale, C-SSRS;Barratt Impulsiveness Scale, BIS;Visual Analogue Scale/Score, VAS;

Countries

China

Contacts

Public ContactChen Hong

The First Affiliated Hospital of Wenzhou Medical University

chengho0347a@126.com+86 135 6625 7067

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026