Using aiTBS to reduce self-injury in depressed patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates the effectiveness of active accelerated intermittent theta burst stimulation (aiTBS) rTMS compared to a placebo in treating non-suicidal self-injury (NSSI) in patients with major depressive disorder and bipolar disorder. The study will involve 60 inpatients aged 12 to 18, who will receive either active or sham aiTBS treatment administered to the left dorso-lateral prefrontal cortex over five days. Clinical ratings will be measured at baseline, after treatment, and at two and four weeks post-treatment to assess changes in mood, sleep, and self-injury behaviors. Various scales will be used to evaluate the efficacy and safety of the treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Mental Health Institute of Second Xiangya Hospital,CSU
  Changsha, Hunan, China Recruiting

Study contacts

• Study coordinator: Renrong Wu, M.D. Ph.D
• Email: wurenrong@csu.edu.cn
• Phone: +8615874179855

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.