Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Launched by MAYO CLINIC · Aug 4, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment method called theta burst stimulation (TBS), which is a type of transcranial magnetic stimulation (TMS). The goal is to see if this treatment can help reduce suicidal thoughts in adolescents who are dealing with Major Depressive Disorder (MDD). The study will last for 10 days, and researchers will follow up with participants for a year to check how they are doing overall.

To participate, young people between the ages of 12 and 18 must be diagnosed with MDD and have certain levels of depression and suicidal thoughts. They can be inpatients or outpatients, meaning they can be staying in a hospital or living at home while receiving treatment. Participants will receive TBS therapy, and their progress will be closely monitored. It's important to note that this trial has specific guidelines about who can join, including some health conditions that might exclude someone from participating. Overall, the study aims to provide valuable information about a promising treatment for adolescents struggling with severe depression and suicidal thoughts.

Gender

ALL

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