Accelerated intermittent theta burst stimulation for adolescents and young adults with depression and suicidal thoughts
Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
This trial will try a fast, noninvasive, MRI-guided brain stimulation (accelerated intermittent theta burst TMS) given over five days to reduce depression and suicidal thoughts in 15–25 year olds recently treated for suicidality.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 15 Years to 25 Years |
| Sex | All |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT07025720 on ClinicalTrials.gov |
What this trial studies
This open-label interventional protocol delivers accelerated intermittent theta burst stimulation (iTBS), a form of MRI-guided transcranial magnetic stimulation, across five consecutive days to participants aged 15–25 with major depressive disorder and recent suicidal ideation. All participants receive MRI scans before and after the treatment course and complete clinical assessments at baseline, 1 week, and 4 weeks post-treatment. Primary outcomes include feasibility and acceptability, with measures of depressive symptoms, suicidal ideation, hospitalization rates, and daily functioning as secondary outcomes. No surgical procedures or investigational drugs are involved.
Who should consider this trial
Good fit: Ideal candidates are English-speaking 15–25 year olds who meet criteria for major depressive disorder, have recent suicidal ideation or recent discharge for suicidality, and can provide informed consent.
Not a fit: Patients with active or untreated psychosis, severe substance use, inability to consent, pregnancy/breastfeeding, contraindications to TMS or MRI, or on interfering medications (e.g., benzodiazepines per PI discretion) may not benefit from this treatment.
Why it matters
Potential benefit: If successful, the treatment could offer a rapid, noninvasive option to reduce suicidal thoughts and depressive symptoms and potentially lower the need for hospitalization.
How similar studies have performed: Accelerated iTBS and other rapid TMS protocols have shown promising, sometimes rapid, reductions in depressive symptoms and suicidal ideation in adults, but evidence in adolescents and young adults is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sacramento, California
- UC Davis Medical Center — Sacramento, California, United States (Recruiting)
Study contacts
- Study coordinator: Se Ri (Sally) Bae, MD
- Email: sebae@ucdavis.edu
- Phone: 213-340-4006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.