Actively Recruiting
Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation
Led by Mayo Clinic · Updated on 2025-05-25
80
Participants Needed
1
Research Sites
295 weeks
Total Duration
On this page
Sponsors
M
Mayo Clinic
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Inpatients or outpatients
- Voluntary clinical patient with capacity to assent and parent/legal guardian with capacity to consent
- Female or male
- Aged 12 to 18 years
- Diagnosed with Major Depressive Disorder based on DSM-5 criteria using MINI Kid or MINI
- Currently in an episode of MDD lasting at least 4 weeks but less than 3 years
- Depressive symptoms with CDRS-R total score of 40 or greater and suicidal ideation score of 3 or more on item 13
- Less than 25% improvement in depressive symptoms between screening and baseline
- Eligible for transcranial magnetic stimulation based on safety criteria
- If female, using medically acceptable birth control
- Taking antidepressant medication if recommended and agreed upon (not required)
You will not qualify if you...
- Diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, or substance use disorders in past year (except caffeine and tobacco)
- IQ less than 70 if clinically indicated
- Positive urine drug screen at baseline
- History of seizures or family history of epilepsy
- Prior treatment with electroconvulsive therapy or TMS
- Use of investigational drugs within 4 weeks prior to baseline
- Prior brain surgery
- Risk for increased intracranial pressure such as brain tumor
- Head trauma with loss of consciousness
- Any true positive findings on TMS safety screening form
- Pregnancy or suspected pregnancy
- Implanted magnetic-sensitive metals in head within 30 cm of treatment coil that cannot be removed
- Implanted medication pumps or cardiac pacemakers
- Any unstable medical condition
- Inability to follow the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
Research Team
C
Charlie Hoth
CONTACT
C
Courtney Caves
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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