aiTBS for NSSI and Suicide in Adolescent Depression

NCT06210100 | Recruiting

• 1 other identifier: TMS20230801
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Non Suicidal Self Injury; Suicidal Ideation; Suicide and Self-harm

Keywords

NSSI; MDD; TMS

Outcome Measures

Primary Outcomes (1)

• Changes in the Deliberate Self-Harm Inventory (DSHI)

  Containing one subscale ranging from 0 to 57 to measure the frequencies of NSSI behavior and one subscale ranging from 0 to 76 to measure the severity of NSSI behavior.

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

Secondary Outcomes (15)

• Changes in Hamilton Anxiety Scale (HAMA)

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

• Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

• Changes in Young's Mania Scale (YMRS)

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

• Changes in Beck Suicidal Scale Inventory (BSI)

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

• Changes in The Clinical Global Impression (CGI)

  Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

Other Outcomes (5)

• Borderline features of patients with NSSI

  Baseline

• Child maltreatment of patients with NSSI

  Baseline

• Fundamental parental style of caregivers of patients with NSSI

  Baseline

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.

Device: Active iTBS

Sham stimulation

SHAM COMPARATOR

Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.

Device: Sham iTBS

Interventions

Active iTBS DEVICE

Mag-TD stimulator

Active stimulation

Sham iTBS DEVICE

Mag-TD stimulator

Sham stimulation

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.
• Patients aged 12-18 years with at least one guardian to monitor them for 3 months
• HAMD-17 Total score ≥18
• 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 )
• Obtain informed consent from patients and guardians

You may not qualify if:

• Substance abusers such as psychoactive drugs or alcohol.
• Severe physical disability and unable to complete follow-up.
• 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.
• Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
• Unable to read, understand and complete the assessment or to cooperate with the investigators.
• Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
• A history or family history of epilepsy and other contraindications to TMS.
• Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, etc.
• Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
• Other examination abnormalities considered to be inappropriate by investigators.

Sponsors & Collaborators

• Central South University: lead

Study Sites (2)

The Second People's Hospital of Dali Bai Autonomous Prefecture

Dali, Yunnan, 671014, China

RECRUITING

Mental Health Institute of Second Xiangya Hospital

Changsha, 410001, China

NOT YET RECRUITING

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Suicide

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jun Yang, M.D.

CONTACT

13577877005; 724397007@qq.com

Jing Huang, M.D. Ph.D

CONTACT

15874290980; jinghuangserena@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized controlled clinical trial testing iTBS versus sham

Study Record Dates

• First Submitted: December 20, 2023
• First Posted: January 18, 2024
• Study Start: January 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: February 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

CN (2)