Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
NCT07025720 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-03-11
Summary
The goal of this clinical trial is to learn if a fast-acting brain stimulation treatment called transcranial magnetic stimulation (TMS) can help people with depression and suicidal thoughts. The treatment is non-invasive (does not involve surgery or medications), is given over 5 days, and uses brain imaging (MRI) to guide which part of the brain to target. This study tests whether this treatment is a helpful and practical option for adolescents and young adults who are depressed and have suicidal thoughts.
We want to see if:
1. This treatment is feasible and acceptable to patients
2. It can reduce depression and suicidal thoughts
3. It can lower the chance of going to the hospital
4. It affects daily functioning (school, work, relationships)
All participants will undergo 5-days of TMS treatment and complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.
Conditions
- Major Depressive Disorder (MDD)
- Suicidal Ideation
Interventions
- DEVICE
-
TMS
The protocol involves delivering sessions of intermittent theta burst stimulation (iTBS) of 60 cycles of 10 bursts of three pulses at 50 Hz were delivered in 2-second trains (5 Hz) with an 8-second intertrain interval. Stimulation sessions will be delivered hourly. Ten sessions will be applied per day (18,000 pulses/day) for 5 consecutive days (90,000 pulses in total). Stimulation will be delivered at 90% resting motor threshold (rMT).
Sponsors & Collaborators
-
Sorensen Foundation
collaborator UNKNOWN -
University of California, Davis
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 15 Years
- Max Age
- 25 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-07-01
- Primary Completion
- 2027-04-30
- Completion
- 2027-05-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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