Back to resultsaiTBS for Relieving NSSI in Depressive Patients
Primary Purpose
Major Depressive Disorder, Bipolar Depression
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Active iTBS
Sham iTBS
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder
Eligibility Criteria
Inclusion Criteria:
- Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
- Ages between 12 and 18 years
- At least 1 caregivers to supervise the patient within 3 month.
- A score of greater than 17 on the HAM-D17.
- Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
- Willingness to participate in the study and sign informed consents
Exclusion Criteria:
- 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 schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
- Currently in a manic episode, YMRS>12; rapid-cycling bipolar disorder.
- 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, trazodone, theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
- Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
- Significant anxiety disorder, HAMA ≥ 21 points.
- Other examination abnormalities considered to be inappropriate by investigators.
Sites / Locations
- Mental Health Institute of Second Xiangya Hospital,CSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
active stimulation
Sham stimulation
Arm Description
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Outcomes
Primary Outcome Measures
Changes in the Deliberate Self-Harm Inventory (DSHI)
Containing three subscales ranging from 0 to 57 each to measure the frequencies of ideation and behavior of NSSI, as well as the severity of NSSI behavior.
Secondary Outcome Measures
Changes in Pittsburgh Sleep Quality Index (PSQI)
Range from 0-21, higher score indicates severe poorer sleep quality
Changes in Hamilton Anxiety Scale (HAMA)
Range from 0-56, higher score indicates more severe symptoms
Changes in Young's Mania Scale (YMRS)
Range from 0-60, higher score indicates more severe symptoms
Changes in Barratt Impulsiveness Scale-11 (BIS-11)
Range from 26-104, higher score indicates higher impulsivity
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.
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).
Changes in Beck Suicidal Scale Inventory (BSI)
Range from 0- 38, higher score indicates more severe suicide ideation.
Changes in The Clinical Global Impression (CGI)
Measuring the symptom severity, overall improvement, and therapeutic response to intervention.
Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory)
Range from 0- 28, higher score indicates higher addiction.
Changes in number of occurrences of Non-Suicidal Self Injurious ideation Through SITBI-R
The frequency of NSSI thoughts during the latest week
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05384405
Brief Title
aiTBS for Relieving NSSI in Depressive Patients
Official Title
Accelerated Intermittent Theta Burst Stimulation for the Treatment of Non-suicidal Self-injury in Patients With Unipolar Depression and Bipolar Depression: a Sham-controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Bipolar Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled clinical trial testing iTBS versus sham
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
active stimulation
Arm Type
Active Comparator
Arm Description
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Arm Title
Sham stimulation
Arm Type
Sham Comparator
Arm Description
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Intervention Type
Device
Intervention Name(s)
Active iTBS
Intervention Description
MagPro X100
Intervention Type
Device
Intervention Name(s)
Sham iTBS
Intervention Description
MagPro X100
Primary Outcome Measure Information:
Title
Changes in the Deliberate Self-Harm Inventory (DSHI)
Description
Containing three subscales ranging from 0 to 57 each to measure the frequencies of ideation and behavior of NSSI, as well as the severity of NSSI behavior.
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Secondary Outcome Measure Information:
Title
Changes in Pittsburgh Sleep Quality Index (PSQI)
Description
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
Title
Changes in Hamilton Anxiety Scale (HAMA)
Description
Range from 0-56, higher score indicates more severe symptoms
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Title
Changes in Young's Mania Scale (YMRS)
Description
Range from 0-60, higher score indicates more severe symptoms
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Title
Changes in Barratt Impulsiveness Scale-11 (BIS-11)
Description
Range from 26-104, higher score indicates higher impulsivity
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Title
Changes in cerebral blood flow of PFC through Near Infrared Spectroscopy (fNIRS)
Description
Measuring the hemoglobin concentration of cerebral cortex during resting state and verbal fluency test.
Time Frame
Baseline, after 5 treatment days
Title
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Description
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
Title
Changes in Beck Suicidal Scale Inventory (BSI)
Description
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
Title
Changes in The Clinical Global Impression (CGI)
Description
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
Title
Changes in the subscale of addiction of NSSI from OSI (Ottawa self-injury inventory)
Description
Range from 0- 28, higher score indicates higher addiction.
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Title
Changes in number of occurrences of Non-Suicidal Self Injurious ideation Through SITBI-R
Description
The frequency of NSSI thoughts during the latest week
Time Frame
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Title
Changes in likelihood of future Non-Suicidal Self Injury Through SITBI-R
Description
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
Other Pre-specified Outcome Measures:
Title
The retrospect of NSSI behavior
Description
Measured by Ottawa self-injury inventory (OSI), including reasons, addiction, site of NSSI, etc.
Time Frame
Baseline
Title
Borderline features of patients with NSSI
Description
Measured by The Borderline Personality Feature Scale for Children - 11 (BPFS-C-11) ranging from 24 to 120
Time Frame
Baseline
Title
Child maltreatment of patients with NSSI
Description
Measured by the Childhood Trauma Questionnaire (CTQ) ranging from 25 to 125.
Time Frame
Baseline
Title
Fundelmental parental style of caregivers of patients with NSSI
Description
Measured by the Parental Bonding Instrument (PBI) containing two subscales ranging from 0 to 75 for both mother and father version.
Time Frame
Baseline
Title
Safety and tolerance of the intervention
Description
Recording any side effects in the adverse event record form (AERF).
Time Frame
After 5 treatment days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
Ages between 12 and 18 years
At least 1 caregivers to supervise the patient within 3 month.
A score of greater than 17 on the HAM-D17.
Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
Willingness to participate in the study and sign informed consents
Exclusion Criteria:
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 schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
Currently in a manic episode, YMRS>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
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, trazodone, theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
Other examination abnormalities considered to be inappropriate by investigators.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renrong Wu, M.D. Ph.D
Phone
+8615874179855
Email
wurenrong@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Jing Huang, M.D.
Email
jinghuangserena001@csu.edu.cn
Facility Information:
Facility Name
Mental Health Institute of Second Xiangya Hospital,CSU
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renrong Wu, PhD, M.D
Phone
15874179855
Email
wurenrong2013@163.com
First Name & Middle Initial & Last Name & Degree
Jing Huang, MD
Email
jinghuangserena001@csu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
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aiTBS for Relieving NSSI in Depressive Patients
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