Clinical trial NCT06210100: aiTBS for NSSI and Suicide in Adolescent Depression
Official title: Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Suicidal Self Injury
Suicidal Ideation
Suicide and Self-harm
Keywords: NSSI
MDD
TMS
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial testing iTBS versus sham
Primary purpose: TREATMENT

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.

Detailed description: The study will evaluate the efficacy and safety of aiTBS in depressive patients with NSSI or suicidal thoughts and behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 4 weeks, 8 weeks after treatment. 60 inpatients will be randomized to receive active or sham interventions administered to the left dorso-lateral prefrontal cortex. The treatment will apply active aiTBS rTMS involving 1800 pulses (9 minutes), 5x daily at 60 minutes intervals for 10 days. Changes in mood from baseline to the end of the study will be measured with The Hamilton Rating Scale for Depression-17 item (HAM-D17), Hamilton Anxiety Scale (HAMA) and Young's Mania Scale (YMRS). Non-suicidal self injury will be assessed by the Deliberate Self-Harm Inventory (DSHI) and the Ottawa self-injury inventory (OSI). Suicidal ideation and behaviors assessments include Beck Suicidal Scale Inventory (BSI), the Columbia-Suicide Severity Rating Scale (C-SSRS), and several questions from Self-Injurious Thoughts and Behaviors Interview - Revised (SITBI-R). The World Health Organization Disability Assessment Schedule for children (WHODAS-Child) will be used to evaluate the overall function of adolescent patients. Treatment Emergent Symptom Scale (TESS) would be used to eliminate side effects of combined drugs at baseline and the adverse event record form (AERF) will be used to appraise the safety of aiTBS treatment using these parameters. Changes of brain structure and brain activities will be acquired by pre and post-interventional magnetic resonance imaging (MRI). Fasting blood exams will be conducted to measuring the level of NSSI related endocrine and metabolic changes. To record the change in sensitivity to pain and examine the tolerability of the treatment for these participants, visual analogue scale (VAS) is employed after completing 5 sessions treatment every day.

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 12-18 years with at least one guardian to monitor them for 3 months
3. HAMD-17 Total score ≥18
4. 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 )
5. 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 structure or function of the brain in the lifetime.
5. Unable to read, understand and complete the assessment or to cooperate with the investigators.
6. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
7. A history or family history of epilepsy and other contraindications to TMS.
8. Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, etc.
9. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
10. Other examination abnormalities considered to be inappropriate by investigators.

Primary outcomes:
measure: Changes in the Deliberate Self-Harm Inventory (DSHI)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Secondary outcomes:
measure: Changes in Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in Young's Mania Scale (YMRS)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in Beck Suicidal Scale Inventory (BSI)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in The Clinical Global Impression (CGI)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
measure: Changes in the The World Health Organization Disability Assessment Schedule for children (WHODAS2-child)
timeFrame: Baseline, 4 week and 8 week post-treatment
measure: Changes of high-resolution T1-weighted anatomical images
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
measure: Changes of Diffusion Tensor Imaging
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
measure: Changes of blood oxygenation level dependent (BOLD) functional imaging signals
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
measure: Changes in plasma β-endorphin
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
measure: Changes in plasma cortisol
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
measure: Changes in serum Brain-derived neurotrophic factor (BDNF)
timeFrame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Other outcomes:
measure: Borderline features of patients with NSSI
timeFrame: Baseline
measure: Child maltreatment of patients with NSSI
timeFrame: Baseline
measure: Fundamental parental style of caregivers of patients with NSSI
timeFrame: Baseline
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: Baseline
measure: Peer relationship of patients with NSSI
timeFrame: Baseline
Locations:
city: Dali
country: China
facility: The Second People's Hospital of Dali Bai Autonomous Prefecture
state: Yunnan
city: Changsha
country: China
facility: Mental Health Institute of Second Xiangya Hospital
Study officials:
References: