aiTBS for NSSI and Suicide in Adolescent Depression
- Conditions
- Non Suicidal Self InjurySuicide and Self-harmSuicidal Ideation
- Interventions
- Device: Active iTBSDevice: Sham iTBS
- Registration Number
- NCT06210100
- Lead Sponsor
- Central South University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Active stimulation Active iTBS Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days. Sham stimulation Sham iTBS Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.
- Primary Outcome Measures
Name Time Method Changes in the Deliberate Self-Harm Inventory (DSHI) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment 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.
- Secondary Outcome Measures
Name Time Method Changes in Hamilton Anxiety Scale (HAMA) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Range from 0-56, higher score indicates more severe symptoms
Changes in Beck Suicidal Scale Inventory (BSI) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Range from 0- 38, higher score indicates more severe suicide ideation.
Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment The C-SSRS is made up of ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of the behavior. The ten categories included in the C-SSRS are as follows: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide.
A yes/no binary response is also utilized in assessing self-injurious behavior without suicidal intent. The outcome of the C-SSRS is a numerical score obtained from the aforementioned categories.Changes in The Clinical Global Impression (CGI) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Containing two subscales ranging from 1 to 7 each to measure the symptom severity and overall improvement respectively. Higher score indicates greater severity or greater improvements.
Changes in the The World Health Organization Disability Assessment Schedule for children (WHODAS2-child) Baseline, 4 week and 8 week post-treatment The WHODAS-Child is a self-report assessment of difficulties in six domains: understanding and communicating ranging from 0 to 24, getting around ranging from 0 to 20, self-care ranging from 0 to 16, getting along with people ranging from 0 to 20, life activities ranging from 0 to 36, and participation in society ranging from 0 to 20. Higher score indicates worse global function.
Changes in plasma β-endorphin Baseline, next day after 10 treatment days, and 8 week post-treatment in ng/ml
Changes in serum Brain-derived neurotrophic factor (BDNF) Baseline, next day after 10 treatment days, and 8 week post-treatment in ng/ml
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 Range from 0-52, higher score indicates more severe symptoms
Changes in Young's Mania Scale (YMRS) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Range from 0-60, higher score indicates more severe symptoms
Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Range from 0- 28, higher score indicates higher addiction.
Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation) Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment Range from 0 to 57 to measure the frequency of NSSI ideation
Changes of high-resolution T1-weighted anatomical images Baseline, next day after 10 treatment days, and 8 week post-treatment Resting-state MRI (rs-MRI) will be used to exam the change of brain structure. T1-weighted images will be acquired using 3D inversion recovery-prepared fast spoiled gradient-echo sequences.
Changes of Diffusion Tensor Imaging Baseline, next day after 10 treatment days, and 8 week post-treatment Resting-state MRI (rs-MRI) will be used to exam the change of brain structure. Diffusion Tensor Imaging (DTI) will be performed using diffusion-weighted echo planar imaging sequences.
Changes of blood oxygenation level dependent (BOLD) functional imaging signals Baseline, next day after 10 treatment days, and 8 week post-treatment Functional MRI (fMRI) will be used to exam the change of brain function.
Changes in plasma cortisol Baseline, next day after 10 treatment days, and 8 week post-treatment in ng/ml
Trial Locations
- Locations (2)
The Second People's Hospital of Dali Bai Autonomous Prefecture
🇨🇳Dali, Yunnan, China
Mental Health Institute of Second Xiangya Hospital
🇨🇳Changsha, China