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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Charlie Hoth
hoth.charlie@mayo.edu
(507) 422-2605
Backup
Courtney Caves
wolf.courtney@mayo.edu
Time Frame
Start Date: 2022-04-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 80
Treatments
Active_comparator: Sequential bilateral accelerated theta burst stimulation
Three sessions of Sequential bilateral accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).
Sham_comparator: Sham seqential billateral accelerated theta burst stimulation
Three sessions of Sequential bilateral sham accelerated theta burst stimulation (aTBS) are administered daily for 10 days (5 days per week).
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Institute of Mental Health (NIMH)

This content was sourced from clinicaltrials.gov

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