Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMayo Clinic
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- MagVenture TMS Therapy System w/Theta Burst Stimulation
- Sham MagVenture TMS Therapy System w/Theta Burst Stimulation
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Mayo Clinic
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov