Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk

Part of paid clinical trials in Sacramento, California.

Sponsor
University of California, Davis
Study ID
NCT07025720
Status
Recruiting
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Conditions

  • Major Depressive Disorder (MDD)
  • Suicidal Ideation

Eligibility Criteria

Sex
ALL
Age
15 Years - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • TMS — DEVICE
    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).

Study Details

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.

Key Dates

Start date
Jul 1, 2025
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
May 31, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TMS

Primary Outcome Measure

Change in MADRS score [ Time Frame: 1 week ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UC Davis Medical CenterSacramentoCalifornia95817
Se Ri Bae, MD
[email protected]
916-244-0832

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By research site
UC Davis Medical Center· Sacramento, CA

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