Using theta burst stimulation to treat suicidal thoughts in adolescents
A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder
This study is testing a new brain stimulation treatment to see if it can help teenagers with major depression who are having suicidal thoughts feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT04502758 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of a novel transcranial magnetic stimulation (TMS) technique called accelerated theta burst stimulation (aTBS) on adolescents experiencing suicidal ideation due to Major Depressive Disorder (MDD). Participants will undergo three daily sessions of aTBS for 10 days, targeting specific areas of the brain associated with mood regulation. The study aims to assess improvements in suicidal thoughts and overall clinical outcomes over a one-year follow-up period. A comparison group will receive sham TMS treatment alongside daily psychotherapy.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 diagnosed with Major Depressive Disorder and experiencing significant suicidal ideation.
Not a fit: Patients who do not meet the age or diagnostic criteria, or those with a history of non-responsiveness to TMS, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce suicidal ideation and improve mental health outcomes in adolescents with MDD.
How similar studies have performed: Previous studies have shown promise with TMS techniques, but this specific approach using aTBS in adolescents is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inpatients or outpatients * Voluntary clinical patient with the capacity to assent to treatment and a parent or legal guardian with the capacity to consent * Female or male * 12-18 years of age * Diagnosed with MDD based on Diagnostic and Statistical Manual for Mental Disorders, 5th edition (DSM-5) criteria122 with the Mini-International Neuropsychiatric Interview for Children and Adolescents (MINI Kid) in subjects 12-17 years of age;118 The Mini-International Neuropsychiatric Interview will be used for subjects who are 18 years of age117 * In a current episode of MDD with duration of at least 4 weeks but less than 3 years * Depressive symptom severity as demonstrated by CDRS-R total composite score of 40 or greater and a suicidal ideation score of 3 or more on item 13 of the CDRS-R109 * Demonstrating that depressive symptom severity as evaluated at the screening visit does not improve between screening and baseline by 25% or more * Eligible for transcranial magnetic stimulation (TMS) based on safety criteria104 * On a medically acceptable form of birth control if female * Taking an antidepressant medication if recommended by the referring clinician and agreed upon by parents and patients. Please note that patients are not required to take an antidepressant medication for study participation for practical, ethical, and human subject protection concerns. Medication status and prior treatment resistance will be carefully recorded with the Antidepressant Treatment History Form113 criteria for relevant statistical considerations. Exclusion Criteria: * Diagnosis of a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, substance use disorders within the past year (with the exception of caffeine and tobacco). * Intelligent quotient less than 70 (if there is a clinical concern, subjects will be psychometrically assessed with the Slosson Intelligence Test, Revised).123 * Positive urine drug screen at baseline * Seizure history * Any family history of epilepsy * History of any treatment with electroconvulsive therapy or TMS * Use of any investigational drug within 4 weeks of baseline * Prior brain surgery * Risk for increased intracranial pressure such as a brain tumor * Head trauma with loss of consciousness * Any true positive findings on the TMS safety screening form * Pregnancy or suspected pregnancy * Conductive, ferromagnetic, or other magnetic-sensitive metals implanted in the head-within 30 cm of the treatment coil excluding the mouth that cannot be safely removed (examples include cochlear implants, vagus nerve stimulators, deep brain stimulators, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, jewelry and hair barrettes). * Implanted medication pumps and cardiac pacemakers * Any unstable medical condition * Inability to adhere to the protocol
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Paul Croarkin, DO, MS — Mayo Clinic
- Study coordinator: Charlie Hoth
- Email: hoth.charlie@mayo.edu
- Phone: (507) 422-2605
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.