Non Suicidal Self InjuryNCT06210100
aiTBS for NSSI and Suicide in Adolescent Depression
A study testing Active iTBS in people with Non Suicidal Self Injury and Suicidal Ideation, run by Central South University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Non Suicidal Self Injury, Suicidal Ideation, Suicide and Self-harm
- What is being tested?
- Active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 18 Jan 2024to 1 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Not yet recruiting
Mental Health Institute of Second Xiangya Hospital
Changsha, 410001
Jing Huang, PhD, 15874290980, jinghuangserena@csu.edu.cn
- Recruiting
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, 671014
Jun Yang
About this study
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
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.
Read the 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.
- Being tested
- Active iTBS, Sham iTBS
- Keywords
- NSSI, MDD, TMS
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active iTBSDevice
Mag-TD stimulator
Sham iTBSDevice
Mag-TD stimulator
| Study group | Role | What they receive |
|---|---|---|
| Active stimulation | Active comparator | Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days. Receives: Device: Active iTBS |
| Sham stimulation | Sham comparator | Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days. Receives: Device: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Secondary outcomes (15)
Changes in Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Measured: 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)
Range from 0-52, higher score indicates more severe symptoms
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in Young's Mania Scale (YMRS)
Range from 0-60, higher score indicates more severe symptoms
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in Beck Suicidal Scale Inventory (BSI)
Range from 0- 38, higher score indicates more severe suicide ideation.
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in The Clinical Global Impression (CGI)
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.
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory)
Range from 0- 28, higher score indicates higher addiction.
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation)
Range from 0 to 57 to measure the frequency of NSSI ideation
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS)
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.
Measured: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the The World Health Organization Disability Assessment Schedule for children (WHODAS2-child)
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.
Measured: Baseline, 4 week and 8 week post-treatment
Changes of high-resolution T1-weighted anatomical images
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.
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes of Diffusion Tensor Imaging
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.
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes of blood oxygenation level dependent (BOLD) functional imaging signals
Functional MRI (fMRI) will be used to exam the change of brain function.
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in plasma β-endorphin
in ng/ml
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in plasma cortisol
in ng/ml
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in serum Brain-derived neurotrophic factor (BDNF)
in ng/ml
Measured: Baseline, next day after 10 treatment days, and 8 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start18 Jan 2024
- Primary completion31 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Suicidal Self InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial testing iTBS versus sham
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06210100
- Sponsor's protocol ID
- TMS20230801
- Status last verified
- Aug 2024
- First submitted
- 20 Dec 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06210100
- Acronym / sponsor ID
- TMS20230801
- Keywords
- NSSI, MDD, TMS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 18 Jan 2024 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial testing iTBS versus sham
| Arm | Type | Receives |
|---|---|---|
| Active stimulation | Active comparator | Device: Active iTBSActive Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days. |
| Sham stimulation | Sham comparator | Device: Sham iTBSSham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active iTBSMag-TD stimulator | Device | Active stimulation |
| Sham iTBSMag-TD stimulator | Device | Sham stimulation |
Primary outcome
Changes in the Deliberate Self-Harm Inventory (DSHI)
Time frame: 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.
15 secondary outcomes
Changes in Hamilton Anxiety Scale (HAMA)
Time frame: 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)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in Young's Mania Scale (YMRS)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in Beck Suicidal Scale Inventory (BSI)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in The Clinical Global Impression (CGI)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Changes in the The World Health Organization Disability Assessment Schedule for children (WHODAS2-child)
Time frame: Baseline, 4 week and 8 week post-treatment
Changes of high-resolution T1-weighted anatomical images
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes of Diffusion Tensor Imaging
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes of blood oxygenation level dependent (BOLD) functional imaging signals
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in plasma β-endorphin
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in plasma cortisol
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Changes in serum Brain-derived neurotrophic factor (BDNF)
Time frame: Baseline, next day after 10 treatment days, and 8 week post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active iTBS in people with Non Suicidal Self Injury and Suicidal Ideation, run by Central South University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Yang, M.D. (13577877005, 724397007@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Deliberate Self-Harm Inventory (DSHI) (time frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.