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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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. 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Mental Health Institute of Second Xiangya Hospital,CSU
RECRUITING
Changsha
Contact Information
Primary
Renrong Wu, M.D. Ph.D
wurenrong@csu.edu.cn
+8615874179855
Backup
Jing Huang, M.D.
jinghuangserena001@csu.edu.cn
Time Frame
Start Date: 2022-07-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 60
Treatments
Active_comparator: active stimulation
Active Intermittent theta burst stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Sham_comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 5 days.
Related Therapeutic Areas
Sponsors
Leads: Central South University

This content was sourced from clinicaltrials.gov