aiTBS for NSSI and Suicide in Adolescent Depression

August 15, 2024 updated by: Renrong Wu, Central South University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Changsha, China, 410001
        • Not yet recruiting
        • Mental Health Institute of Second Xiangya Hospital
        • Contact:
    • Yunnan
      • Dali, Yunnan, China, 671014
        • Recruiting
        • The Second People's Hospital of Dali Bai Autonomous Prefecture
        • Contact:
          • Jun Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active stimulation
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.
Device: Active iTBS
Mag-TD stimulator
Sham Comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.
Device: Sham iTBS
Mag-TD stimulator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Hamilton Anxiety Scale (HAMA)
Time Frame: Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment
Range from 0-56, higher score indicates more severe symptoms
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
Range from 0-52, higher score indicates more severe symptoms
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
Range from 0-60, higher score indicates more severe symptoms
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
Range from 0- 38, higher score indicates more severe suicide ideation.
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
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.
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
Range from 0- 28, higher score indicates higher addiction.
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
Range from 0 to 57 to measure the frequency of NSSI ideation
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

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.
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
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.
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
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.
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
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.
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
Functional MRI (fMRI) will be used to exam the change of brain function.
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
in ng/ml
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
in ng/ml
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
in ng/ml
Baseline, next day after 10 treatment days, and 8 week post-treatment

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Borderline features of patients with NSSI
Time Frame: Baseline
Measured by The Borderline Personality Feature Scale for Children-11 (BPFS-C-11) ranging from 24 to 120. Higher score indicates stronger borderline personality tendency.
Baseline
Child maltreatment of patients with NSSI
Time Frame: Baseline
Measured by the Childhood Trauma Questionnaire (CTQ) ranging from 25 to 125. Higher score indicates more adversity experienced in childhood.
Baseline
Fundamental parental style of caregivers of patients with NSSI
Time Frame: Baseline
Measured by the Parental Bonding Instrument (PBI) containing two subscales ranging from 0 to 75 for both mother and father version. Each subscale include 25 item questions, including 12 'care' items and 13 'overprotection' items. For mothers, a care score of 27.0 indicates higher care and a protection score of 13.5 indicates high protection. For fathers, a care score of 24.0 indicates high care and a protection score of 12.5 indicates high protection. high and low categories of care and protection can be combined into four parental bonding types of affectionate constraint, affectionless control, optimal parenting, and neglectful parenting.
Baseline
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time Frame: Baseline
Recording any side effects in the adverse event record form (AERF).
Baseline
Peer relationship of patients with NSSI
Time Frame: Baseline
Measured by the Peer relationship questionnaire (PRQ) containing 22 items scoring from 22 to 88. The higher the scores on the questionnaire indicate the worse the peer relationships.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Central South University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TMS20230801

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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