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Depression

Sequential Bilateral Accelerated Theta Burst Stimulation in Adolescents With Suicidal Ideation

Recruiting · Rochester, Minnesota

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Interpreters available

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Your choice

Voluntary — you can stop anytime

What is this study?

This study is testing a new brain stimulation treatment called theta burst stimulation (TBS) to see if it can reduce suicidal thoughts in teens with major depressive disorder (MDD). Participants will be followed for 10 days for symptom changes and for 1 year for longer-term outcomes.

It is , overseen by an independent and licensed medical staff.

Read the full clinical 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.

Who this study is looking for

In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.

✅ You may be able to join if…

  • Teens who are 12 to 18 years old
  • Have been diagnosed with major depressive disorder (MDD) using DSM-5 criteria and MINI Kid (or MINI for age 18)
  • Are in a current MDD episode lasting at least 4 weeks but less than 3 years
  • Have depression and suicidal thoughts that meet study scores on the CDRS-R (total score 40+ and item 13 score 3+)
  • Can meet TMS safety requirements and have a parent/guardian who can consent (and the teen can assent)

🚫 You may not be able to join if…

  • Have a psychotic disorder, bipolar disorder, anorexia nervosa, bulimia nervosa, or substance use disorders within the past year (except caffeine and tobacco)
  • Have an IQ less than 70 (if there is concern, they will be tested with the Slosson Intelligence Test, Revised)
  • Have a positive urine drug test at baseline
  • Have a history of seizures, any family history of epilepsy, or risk factors listed (like increased pressure in the head such as a brain tumor, or head trauma with loss of consciousness)
  • Have had electroconvulsive therapy (ECT) or TMS before, have had brain surgery, have any true positive TMS safety screening result, are pregnant/suspected pregnant, or cannot safely have the TMS due to certain implanted metal/medical devices

Are you a good fit?

Simplified highlights. The study team always confirms the full details with you.

  • Adults roughly 12–18
  • Have Type 2 diabetes
  • !Not for people who are pregnant or breastfeeding

What to expect, step by step

  1. 1

    Usually a few weeks

    The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.

  2. 2

    Treatment

    If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.

  3. 3

    Follow-up

    After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.

Has this treatment been tested before?

The study team can share what safety testing has been done so far.

What you need to know before you apply

What is this study testing?+

This study is testing a new brain stimulation treatment called theta burst stimulation (TBS) to see if it can reduce suicidal thoughts in teens with major depressive disorder (MDD). Participants will be followed for 10 days for symptom changes and for 1 year for longer-term outcomes.

Is it safe? Who makes sure of that?+

This is a research study. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.

Will I get a placebo instead of the real treatment?+

Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.

Do I have to stop taking my current medications?+

It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.

Does it cost anything? Will I be paid?+

Study-related care is provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.

Do I need insurance? Will anyone ask about my immigration status?+

No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.

What if English isn't my first language?+

You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.

Is my information private?+

Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.

Some requirements (like specific lab values or timing) are confirmed directly by the study team, not by us.

Source: ClinicalTrials.gov · NCT04502758 · Locations: Minnesota