NCT04502758 Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation
| NCT ID | NCT04502758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mayo Clinic |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-04-04 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2022-04-04 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to gather information regarding the use of a new type of transcranial magnetic stimulation (TMS) called theta burst stimulation (TBS) for suicidal ideation in adolescents with Major Depressive Disorder (MDD). The investigators hope to learn if this TMS treatment improves suicidal ideation over 10 days and clinical outcomes over 1 year of follow-up.
Eligibility 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
Contact & Investigator
Paul Croarkin, DO, MS
PRINCIPAL INVESTIGATOR
Mayo Clinic
Frequently Asked Questions
Who can join the NCT04502758 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04502758 currently recruiting?
Yes, NCT04502758 is actively recruiting participants. Contact the research team at hoth.charlie@mayo.edu for enrollment information.
Where is the NCT04502758 trial being conducted?
This trial is being conducted at Rochester, United States.
Who is sponsoring the NCT04502758 clinical trial?
NCT04502758 is sponsored by Mayo Clinic. The principal investigator is Paul Croarkin, DO, MS at Mayo Clinic. The trial plans to enroll 80 participants.