- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05384405
aiTBS for Relieving NSSI in Depressive Patients
April 24, 2024 updated by: Renrong Wu, Central South University
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- 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
- Name: Renrong Wu, M.D. Ph.D
- Phone Number: +8615874179855
- Email: wurenrong@csu.edu.cn
Study Contact Backup
- Name: Jing Huang, M.D.
- Email: jinghuangserena001@csu.edu.cn
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410011
- Recruiting
- Mental Health Institute of Second Xiangya Hospital,CSU
-
Contact:
- Renrong Wu, PhD, M.D
- Phone Number: 15874179855
- Email: wurenrong2013@163.com
-
Contact:
- Jing Huang, MD
- Email: jinghuangserena001@csu.edu.cn
-
-
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
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Description
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 (more than 2mg/d), 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.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: active stimulation
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
|
MagPro X100
|
Sham Comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
|
MagPro X100
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in the Deliberate Self-Harm Inventory (DSHI)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 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, after 5 treatment days, 2 week and 4 week post-treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in number of occurrences of Non-Suicidal Self Injurious ideation Through SITBI-R
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
The frequency of NSSI thoughts during the latest week
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in likelihood of future Non-Suicidal Self Injury Through SITBI-R
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0-4, higher score indicates more likelihood to conduct NSSI in the future
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD-17)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
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).
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0-21, higher score indicates severe poorer sleep quality
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in Hamilton Anxiety Scale (HAMA)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0-56, higher score indicates more severe symptoms
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in Young's Mania Scale (YMRS)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0-60, higher score indicates more severe symptoms
|
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)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0- 28, higher score indicates higher addiction.
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in Barratt Impulsiveness Scale-11 (BIS-11)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 26-104, higher score indicates higher impulsivity
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in cerebral blood flow of PFC through Near Infrared Spectroscopy (fNIRS)
Time Frame: Baseline, after 5 treatment days
|
Measuring the hemoglobin concentration of cerebral cortex during resting state and verbal fluency test.
|
Baseline, after 5 treatment days
|
Changes in Beck Suicidal Scale Inventory (BSI)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0- 38, higher score indicates more severe suicide ideation.
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in The Clinical Global Impression (CGI)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Measuring the symptom severity, overall improvement, and therapeutic response to intervention.
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation)
Time Frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Range from 0 to 57 to measure the frequency of NSSI ideation
|
Baseline, after 5 treatment days, 2 week and 4 week post-treatment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The retrospect of NSSI behavior
Time Frame: Baseline
|
Measured by Ottawa self-injury inventory (OSI), including reasons, addiction, site of NSSI, etc.
|
Baseline
|
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
|
Baseline
|
Fundelmental 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.
|
Baseline
|
Safety and tolerance of the intervention
Time Frame: After 5 treatment days
|
Recording any side effects in the adverse event record form (AERF).
|
After 5 treatment days
|
Child maltreatment of patients with NSSI
Time Frame: Baseline
|
Measured by the Childhood Trauma Questionnaire (CTQ) ranging from 25 to 125.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
July 1, 2022
Primary Completion (Estimated)
February 28, 2025
Study Completion (Estimated)
February 28, 2025
Study Registration Dates
First Submitted
May 13, 2022
First Submitted That Met QC Criteria
May 19, 2022
First Posted (Actual)
May 20, 2022
Study Record Updates
Last Update Posted (Estimated)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TMS20220425
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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