Actively Recruiting

Phase Not Applicable
Age: 12Years - 18Years
All Genders
NCT06210100

aiTBS for NSSI and Suicide in Adolescent Depression

Led by Central South University · Updated on 2024-08-16

60

Participants Needed

2

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

aiTBS for NSSI and Suicide in Adolescent Depression

Who Can Participate

Age: 12Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Meet the DSM-5 diagnostic criteria for major depressive disorder
  • Aged 12 to 18 years with at least one guardian to monitor them for 3 months
  • Hamilton Depression Rating Scale (HAMD-17) total score of 18 or higher
  • Hospitalized with two or more non-suicidal self-injury behaviors in the week before admission
  • Non-suicidal self-injury behavior on more than 5 days in the past year
  • Baseline Deliberate Self-Harm Inventory (DSHI) score of 2 or higher
  • Informed consent obtained from patient and guardian
Not Eligible

You will not qualify if you...

  • Substance abuse of psychoactive drugs or alcohol
  • Severe physical disability preventing follow-up
  • Other major mental illnesses meeting DSM-5 criteria (e.g., bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, ADHD)
  • Severe physical, neurological disease, or traumatic brain injury affecting brain structure or function
  • Unable to read, understand, complete assessments, or cooperate with investigators
  • Implanted pacemaker, metal, or magnetic objects in the body or other conditions unsuitable for rTMS
  • History or family history of epilepsy or other contraindications to TMS
  • Daily use of benzodiazepines (>2mg/day), theophylline, stimulants, anticonvulsants
  • Received systematic psychotherapy or TMS within 3 months before baseline
  • Other examination abnormalities deemed inappropriate by investigators

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, China, 671014

Actively Recruiting

2

Mental Health Institute of Second Xiangya Hospital

Changsha, China, 410001

Not Yet Recruiting

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Research Team

J

Jun Yang, M.D.

CONTACT

J

Jing Huang, M.D. Ph.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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