Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression

Status: Recruiting
Location: See all (2) locations...
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 with and 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) and suicidal attempts in patients with major depressive disorder.

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

• Meet the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5th Edition) diagnostic criteria for major depressive disorder.

• Patients aged 12-18 years with at least one guardian to monitor them for 3 months

• HAMD-17 Total score ≥18

• Hospitalized patients who had two or more non-suicidal self-injury behaviors meeting the DSM-5 diagnostic criteria in the week before admission (NSSI behavior of more than 5 days in the past year, and a baseline DSHI score ≥2 )

• Obtain informed consent from patients and guardians

Locations
Other Locations
China
Mental Health Institute of Second Xiangya Hospital
NOT_YET_RECRUITING
Changsha
The Second People's Hospital of Dali Bai Autonomous Prefecture
RECRUITING
Dali
Contact Information
Primary
Jun Yang, M.D.
724397007@qq.com
13577877005
Backup
Jing Huang, M.D. Ph.D
jinghuangserena@csu.edu.cn
15874290980
Time Frame
Start Date: 2024-01-18
Estimated Completion Date: 2025-02-01
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 10 days.
Sham_comparator: Sham stimulation
Sham stimulation to the dorsolateral prefrontal cortex; 5 sessions per day, for 10 days.
Related Therapeutic Areas
Sponsors
Leads: Central South University

This content was sourced from clinicaltrials.gov