Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TMS.
- Who it may be relevant to
- Registry conditions: Major Depressive Disorder (MDD), Suicidal Ideation. Basic parameters: 15 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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).
Primary outcome measures
- Change in MADRS score [Time frame: 1 week]
Secondary outcome measures (3)
- Change in C-SSRS score [Time frame: 1 week]
- Health utilization rate [Time frame: 1 week, 1 month]
- Change in Q_LES_Q_SF score [Time frame: 1 week and 1 month]
Eligibility criteria
Inclusion criteria
- English speaking
- Able to provide informed consent
- age 15-25 years
- Discharged within the past week from the ED for chief complaint of SI OR recently admitted in urgent health care setting or seen in outpatient clinic for depression-related suicidal ideation
- Meets MDD criteria per the Mini International Neuropsychiatric Interview (MINI)
Exclusion criteria
- Unable to consent (due to medical condition, psychosis, substance use, etc)
- Use of benzodiazepines or medications that would interfere with TMS treatment as per PI discretion
- Active substance use or severe substance use that in the opinion of the PI would interfere with study participation
- Untreated, active psychosis
- Female patient who is breastfeeding, pregnant or who is planning a pregnancy during the study
- Participation in any clinical study with exposure to any investigational treatment or product within the previous 30 days, or plan on concurrent participation in other studies
- Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- UC Davis Medical Center — Sacramento
Identifiers
NCT: NCT07025720 · 2227384