RECRUITING

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Conditions

Suicidal Ideation Major Depressive Disorder Adolescent

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Controlled Trial of Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation Associated With Major Depressive Disorder

Quick Facts

Study Start:2022-04-04

Study Completion:2027-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04502758

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Charlie Hoth

CONTACT

(507) 422-2605

hoth.charlie@mayo.edu

Courtney Caves

CONTACT

wolf.courtney@mayo.edu

Principal Investigator

Paul Croarkin, DO, MS

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Paul Croarkin, DO, MS, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-04-04

Study Completion Date2027-12

Study Record Updates

Study Start Date2022-04-04

Study Completion Date2027-12

Terms related to this study

Keywords Provided by Researchers

Adolescent

Additional Relevant MeSH Terms

Suicidal Ideation
Major Depressive Disorder