aiTBS for NSSI and Suicide in Adolescent Depression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorCentral South University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 )
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Active iTBS
DeviceMag-TD stimulator
Sham iTBS
DeviceMag-TD stimulator
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Active stimulationActive comparator 1 intervention
Group B: Sham stimulationSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatmentSecondary outcomes
1
Changes in Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Time frame
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment2
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Range from 0-52, higher score indicates more severe symptoms
Time frame
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment3
Changes in Young's Mania Scale (YMRS)
Range from 0-60, higher score indicates more severe symptoms
Time frame
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatment4
Changes in Beck Suicidal Scale Inventory (BSI)
Range from 0- 38, higher score indicates more severe suicide ideation.
Time frame
Baseline, next day after 10 treatment days, 4 week and 8 week post-treatmentOther outcomes
1
Borderline features of patients with NSSI
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.
Time frame
Baseline2
Child maltreatment of patients with NSSI
Measured by the Childhood Trauma Questionnaire (CTQ) ranging from 25 to 125. Higher score indicates more adversity experienced in childhood.
Time frame
Baseline3
Fundamental parental style of caregivers of patients with NSSI
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.
Time frame
Baseline4
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Recording any side effects in the adverse event record form (AERF).
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov