Status:
RECRUITING
aiTBS for Relieving NSSI in Depressive Patients
Lead Sponsor:
Central South University
Conditions:
Major Depressive Disorder
Bipolar Depression
Eligibility:
All Genders
12-18 years
Phase:
NA
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 ide...
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, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05384405
Start Date
July 1 2022
End Date
February 28 2025
Last Update
May 1 2024
Active Locations (1)
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1
Mental Health Institute of Second Xiangya Hospital,CSU
Changsha, Hunan, China, 410011