aiTBS for Relieving NSSI in Depressive Patients (NCT05384405) | Clinical Trial Compass
UnknownNot Applicable
aiTBS for Relieving NSSI in Depressive Patients
China60 participantsStarted 2022-07-01
Plain-language 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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the Deliberate Self-Harm Inventory (DSHI)
Timeframe: Baseline, after 5 treatment days, 2 week and 4 week post-treatment
. Substance abusers such as psychoactive drugs or alcohol.
. Severe physical disability and unable to complete follow-up.
. 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.
. Currently in a manic episode, YMRS\>12; rapid-cycling bipolar disorder, bipolar disorder with mixed features.
. Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in the lifetime.
. Unable to read, understand and complete the assessment or to cooperate with the investigators.
. Any implants covering a pacemaker, metallic or magnetic objects in the body, or other conditions not suitable for rTMS.
. A history or family history of epilepsy and other contraindications to TMS.