BridgeMD
New treatment option for Non Suicidal Self Injury
Official title aiTBS for NSSI and Suicide in Adolescent Depression
ClinicalTrials.gov ID: NCT06210100
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 18
You may be able to join if
- 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...
- Obtain informed consent from patients and guardians
You likely can't join if
- 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 bipolar disorder, schizophrenia, mental retardation, dementia, severe...
- Suffering from any severe physical disease, neurological disease, traumatic brain injury, etc, that affects the structure or function of the brain in...
- 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.
See the full eligibility criteria
- 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...
- Obtain informed consent from patients and guardians
- 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 bipolar disorder, schizophrenia, mental retardation, dementia, severe cognitive impairment, attention deficit hyperactivity disorder, etc.
- 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.
- Daily use of benzodiazepines (more than 2mg/d), theophylline, stimulants such as methylphenidate, anticonvulsants, etc.
- Those who have received systematic psychotherapy (interpersonal relationship therapy, dynamic therapy, cognitive behavioral therapy) or TMS within 3 months before baseline.
- Other examination abnormalities considered to be inappropriate by investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Dali, Yunnan, China
- Changsha, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Dali, Yunnan, China; Changsha, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.