Actively Recruiting
Efficacy and Safety of Accelerated Intermittent Theta Burst Stimulation on Non-suicidal Self-injury and Suicide Behaviors in Adolescents With Unipolar or Bipolar Depression
Led by Central South University · Updated on 2024-08-16
60
Participants Needed
2
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the use of accelerated intermittent theta burst stimulation (aiTBS), a form of repetitive transcranial magnetic stimulation (rTMS), in adolescents aged 12 to 18 years with major depressive disorder who have experienced non-suicidal self-injury (NSSI) or suicidal thoughts and behaviors. This trial aims to compare the effects of active aiTBS to a placebo (sham) treatment on reducing self-injury and suicidal behavior, assessing changes in clinical symptoms and brain function. The study is conducted with hospitalized patients and includes careful safety monitoring due to the sensitive nature of the conditions. Participants will be randomly assigned to receive either active or sham aiTBS treatments applied to the left dorsolateral prefrontal cortex. The active treatment consists of 1800 pulses delivered in 9-minute sessions, five times per day, with 60-minute intervals between sessions, for 10 consecutive days. The sham group will receive a placebo stimulation schedule matching the active treatment. Magnetic resonance imaging (MRI) scans will be performed before and after the treatment period to observe changes in brain structure and activity. Blood tests will monitor endocrine and metabolic changes related to NSSI, and pain sensitivity will be tracked daily. Throughout the study, participants will undergo assessments at baseline, immediately after the 10-day treatment, and at 4 and 8 weeks post-treatment. These evaluations include depression and anxiety rating scales, suicide and self-injury inventories, functional disability assessments, and monitoring for treatment side effects. The primary outcome is the change in self-harm behavior measured by the Deliberate Self-Harm Inventory. Safety will be closely observed using symptom scales and adverse event records, ensuring participant well-being during the trial lasting approximately 8 weeks post-treatment.
CONDITIONS
Brief Title
aiTBS for NSSI and Suicide in Adolescent Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet DSM-5 criteria for major depressive disorder
- Aged 12 to 18 years with at least one guardian available to monitor for 3 months
- Hamilton Depression Rating Scale (HAMD-17) total score of at least 18
- Hospitalized with two or more non-suicidal self-injury behaviors in the week before admission
- History of NSSI behaviors on more than 5 days in the past year and baseline DSHI score of at least 2
- Provide informed consent from patient and guardian
You will not qualify if you...
- Abuse of psychoactive drugs or alcohol
- Severe physical disability preventing follow-up
- Other major mental illnesses like bipolar disorder, schizophrenia, dementia, ADHD
- Severe physical or neurological diseases affecting brain structure or function
- Unable to understand or complete assessments or cooperate with investigators
- Presence of implants like pacemakers or metallic/magnetic objects incompatible with rTMS
- History or family history of epilepsy or other TMS contraindications
- Daily use of certain medications such as benzodiazepines over 2mg/day, stimulants, or anticonvulsants
- Received psychotherapy or TMS in the 3 months before baseline
- Other medical examination abnormalities deemed inappropriate by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 days
Participants receive active or sham intermittent theta burst stimulation to the dorsolateral prefrontal cortex, with 5 sessions per day for 10 days.
Daily visits for 10 days
Duration - 8 weeks
Participants are assessed for changes in self-injury, depression, anxiety, suicidal ideation, brain imaging, and blood markers at 4 and 8 weeks after treatment.
2 visits (4 week and 8 week post-treatment)
Trial Site Locations
Total: 2 locations
1
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China, 671014
Actively Recruiting
2
Mental Health Institute of Second Xiangya Hospital
Changsha, China, 410001
Not Yet Recruiting
Research Team
J
Jun Yang, M.D.
J
Jing Huang, M.D. Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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