An interventional study of Active iTBS and Sham iTBS in Major Depressive Disorder and Bipolar Depression, sponsored by Central South University. Recruiting at 1 site in China. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-05-01.
Sponsored by Central South University · Not applicable, Interventional, and Treatment
Repetitive transcranial magnetic stimulation (rTMS) has been successfully used to help patients with treatment resistant depression. However, its role in alleviating self injuries 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) in patients with unipolar disorder and bipolar disorder.
The study will evaluate the efficacy and safety of aiTBS in unipolar and bipolar depressive patients with NSSI or suicidal thoughts and behaviors by measuring changes in clinical ratings at baseline, after all the treatments, and 2 weeks, 4 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 5 days. Changes in mood and sleep 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), Young's Mania Scale (YMRS), and Pittsburgh Sleep Quality Index (PSQI) . 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 Ottawa self-injury inventory (OSI) and several questions from Self-Injurious Thoughts and Behaviors Interview - Revised (SITBI-R). Improvement of cognitive dysfunction could be measured by Barratt Impulsiveness Scale-11 (BIS-11), near infrared spectroscopy (fNIRS). 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. 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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →Central South University is the lead sponsor of 126 studies on the registry; 29 are open to participants now.
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Exclusion Criteria:
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Active iTBS
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Device: Sham iTBS
MagPro X100
MagPro X100
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, after 5 treatment days, 2 week and 4 week post-treatment
Changes in Pittsburgh Sleep Quality Index (PSQI)
Range from 0-21, higher score indicates severe poorer sleep quality
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in Young's Mania Scale (YMRS)
Range from 0-60, higher score indicates more severe symptoms
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in Barratt Impulsiveness Scale-11 (BIS-11)
Range from 26-104, higher score indicates higher impulsivity
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in cerebral blood flow of PFC through Near Infrared Spectroscopy (fNIRS)
Measuring the hemoglobin concentration of cerebral cortex during resting state and verbal fluency test.
Time frame: Baseline, after 5 treatment days
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
This will be measured as both a continuous variable (scores on HAMD-17 ) and a categorical one (i.e. the response rates of \>50% reduction from baseline HAMD-17 and remission rates defined as HAMD-17 \<7).
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in Beck Suicidal Scale Inventory (BSI)
Range from 0- 38, higher score indicates more severe suicide ideation.
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in The Clinical Global Impression (CGI)
Measuring the symptom severity, overall improvement, and therapeutic response to intervention.
Time frame: Baseline, after 5 treatment days, 2 week and 4 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.
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in number of occurrences of Non-Suicidal Self Injurious ideation Through SITBI-R
The frequency of NSSI thoughts during the latest week
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Changes in likelihood of future Non-Suicidal Self Injury Through SITBI-R
Range from 0-4, higher score indicates more likelihood to conduct NSSI in the future
Time frame: Baseline, after 5 treatment days, 2 week and 4 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
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
The retrospect of NSSI behavior
Measured by Ottawa self-injury inventory (OSI), including reasons, addiction, site of NSSI, etc.
Time frame: Baseline
Borderline features of patients with NSSI
Measured by The Borderline Personality Feature Scale for Children - 11 (BPFS-C-11) ranging from 24 to 120
Time frame: Baseline
Child maltreatment of patients with NSSI
Measured by the Childhood Trauma Questionnaire (CTQ) ranging from 25 to 125.
Time frame: Baseline
Fundelmental 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.
Time frame: Baseline
Safety and tolerance of the intervention
Recording any side effects in the adverse event record form (AERF).
Time frame: After 5 treatment days
Plan to share: No
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