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

NCT07025720 | Recruiting DMC FDA Device

• 1 other identifier: 2227384
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 1.This treatment is feasible and acceptable to patients
2. 2.It can reduce depression and suicidal thoughts
3. 3.It can lower the chance of going to the hospital
4. 4.It affects daily functioning (school, work, relationships)

Conditions

Major Depressive Disorder (MDD); Suicidal Ideation

Keywords

TMS; MDD; Suicidal ideation; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Change in MADRS score

  Change in depressive symptoms as measured by The Montgomery-Åsberg Depression Rating Scale (MADRS) from baseline to post-rTMS treatment. MADRS scores range from 0 to 60, with higher scores reflecting greater severity of depressive symptoms.

  1 week

Secondary Outcomes (3)

• Change in C-SSRS score

  1 week

• Health utilization rate

  1 week, 1 month

• Change in Q_LES_Q_SF score

  1 week and 1 month

Other Outcomes (1)

• Changes in Functional Connectivity

  1 week, 1 month

Study Arms (1)

TMS

EXPERIMENTAL

Device: TMS

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).

TMS

Eligibility Criteria

• Age: 15 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Sorensen Foundation: collaborator

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Suicidal Ideation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Se Ri (Sally) Bae, MD

CONTACT

213-340-4006; sebae@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Resident

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: June 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

US (1)