RECRUITINGINTERVENTIONAL
aiTBS for Relieving NSSI in Depressive Patients
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
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 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.
Who May Be Eligible (Plain English)
Who May Qualify:
1. Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
2. Ages between 12 and 18 years
3. At least 1 caregivers to supervise the patient within 3 month.
4. A score of greater than 17 on the HAM-D17.
5. Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
6. Willingness to participate in the study and sign willing to sign a consent forms
Who Should NOT Join This Trial:
1. Substance abusers such as psychoactive drugs or alcohol.
2. Severe physical disability and unable to complete follow-up.
3. 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.
4. Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
5. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
6. Unable to read, understand and complete the assessment or to cooperate with the investigators.
7. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
8. A history or family history of epilepsy and other contraindications to TMS.
9. Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
10. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
11. Other examination abnormalities considered to be inappropriate by investigators.
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
1. Documentation of DSM-5 criteria for current major depressive disorder (MDD) or bipolar disorder (BD) will be required for study entry.
2. Ages between 12 and 18 years
3. At least 1 caregivers to supervise the patient within 3 month.
4. A score of greater than 17 on the HAM-D17.
5. Occurrences of self injury behavior consistent with the DSM-5 criteria of NSSI more than 3 times in a month.
6. Willingness to participate in the study and sign informed consents
Exclusion Criteria:
1. Substance abusers such as psychoactive drugs or alcohol.
2. Severe physical disability and unable to complete follow-up.
3. 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.
4. Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
5. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
6. Unable to read, understand and complete the assessment or to cooperate with the investigators.
7. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
8. A history or family history of epilepsy and other contraindications to TMS.
9. Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, bupropion, etc.
10. Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) within 3 months before baseline.
11. Other examination abnormalities considered to be inappropriate by investigators.
Treatments Being Tested
DEVICE
Active iTBS
MagPro X100
DEVICE
Sham iTBS
MagPro X100
Locations (1)
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, China