Using aiTBS to reduce self-injury in depressed 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

This study is testing if a new brain stimulation treatment can help teenagers with depression reduce self-injury behaviors.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 12 Years to 18 Years
• Sex: All
• Sponsor: Central South University (Academic / other)
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05384405 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12 to 18 with major depressive disorder or bipolar disorder who exhibit non-suicidal self-injury behaviors.

Not a fit: Patients with severe physical disabilities, substance abuse issues, or other major mental illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce self-injury behaviors in adolescents suffering from depression.

How similar studies have performed: Previous studies have shown that rTMS can be effective for treatment-resistant depression, but the specific application of aiTBS for NSSI is relatively novel.

Eligibility criteria

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 this trial is running

Changsha, Hunan

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

Study contacts

• Study coordinator: Renrong Wu, M.D. Ph.D

Conditions Major Depressive Disorder; Bipolar Depression