Major Depressive DisorderNCT05384405
aiTBS for Relieving NSSI in Depressive Patients
A study testing Active iTBS in people with Major Depressive Disorder and Bipolar Depression, run by Central South University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Depression
- What is being tested?
- Active iTBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Jing Huang, M.D. contact
China1 site, 1 recruiting
- Recruiting
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, 410011
Renrong Wu, PhD, M.D, 15874179855, wurenrong2013@163.com
Jing Huang, MD, jinghuangserena001@csu.edu.cn
About this study
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
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Being tested
- Active iTBS, Sham iTBS
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active iTBSDevice
MagPro X100
Sham iTBSDevice
MagPro X100
| Study group | Role | What they receive |
|---|---|---|
| active stimulation | Active comparator | Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. Receives: Device: Active iTBS |
| Sham stimulation | Sham comparator | Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. Receives: Device: Sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Secondary outcomes (12)
Changes in Pittsburgh Sleep Quality Index (PSQI)
Range from 0-21, higher score indicates severe poorer sleep quality
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start1 Jul 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial testing iTBS versus sham
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renrong Wu, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05384405
- Sponsor's protocol ID
- TMS20220425
- Status last verified
- Apr 2024
- First submitted
- 13 May 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05384405
- Acronym / sponsor ID
- TMS20220425
- Conditions
- Major Depressive Disorder, Bipolar Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial testing iTBS versus sham
| Arm | Type | Receives |
|---|---|---|
| active stimulation | Active comparator | Device: Active iTBSActive Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
| Sham stimulation | Sham comparator | Device: Sham iTBSSham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active iTBSMagPro X100 | Device | active stimulation |
| Sham iTBSMagPro X100 | Device | Sham stimulation |
Primary outcome
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.
12 secondary outcomes
Changes in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 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
Changes in Young's Mania Scale (YMRS)
Time frame: 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
Changes in cerebral blood flow of PFC through Near Infrared Spectroscopy (fNIRS)
Time frame: Baseline, after 5 treatment days
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
Changes in Beck Suicidal Scale Inventory (BSI)
Time frame: 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
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
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
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
Changes in the Deliberate Self-Harm Inventory-ideation (DSHI-ideation)
Time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Huang, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active iTBS in people with Major Depressive Disorder and Bipolar Depression, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renrong Wu, M.D. Ph.D (+8615874179855, wurenrong@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the Deliberate Self-Harm Inventory (DSHI) (time frame: Baseline, after 5 treatment days, 2 week and 4 week post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.