Transcranial Magnetic Stimulation for Depression
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that taking an antidepressant is not required for participation, and medication status will be recorded.
What data supports the effectiveness of the treatment MagVenture TMS Therapy System with Theta Burst Stimulation for depression?
Research shows that theta burst stimulation (TBS), a type of repetitive transcranial magnetic stimulation (rTMS), can be effective for treating major depression. Studies indicate that TBS is a promising option due to its shorter treatment duration and lower intensity, which may improve the efficiency of rTMS for depression.12345
How is the MagVenture TMS Therapy System with Theta Burst Stimulation different from other depression treatments?
The MagVenture TMS Therapy System with Theta Burst Stimulation (TBS) is unique because it uses a patterned form of magnetic stimulation that is shorter in duration and lower in intensity compared to traditional repetitive transcranial magnetic stimulation (rTMS), potentially improving efficiency and allowing for accelerated treatment schedules.12456
Research Team
Paul Croarkin, DO, MS
Principal Investigator
Mayo Clinic
Eligibility Criteria
Adolescents aged 12-18 with Major Depressive Disorder and suicidal thoughts can join this trial. They must have a depressive episode lasting at least 4 weeks but under 3 years, and not show significant improvement before the trial starts. Participants need consent from a guardian, may be on antidepressants, and females must use birth control.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive sequential bilateral accelerated theta burst stimulation (aTBS) or sham TBS, with three sessions administered daily for 10 days
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of suicidal ideation and hospitalizations
Treatment Details
Interventions
- MagVenture TMS Therapy System w/Theta Burst Stimulation
- Sham MagVenture TMS Therapy System w/Theta Burst Stimulation
MagVenture TMS Therapy System w/Theta Burst Stimulation is already approved in United States, European Union for the following indications:
- Major Depressive Disorder (MDD) with suicidal ideation
- Major Depressive Disorder (MDD) with suicidal ideation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator