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NCT Number: NCT07025720

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

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.

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Self-Injurious Behavior Suicidal Ideation Suicide

Age range

15 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Location status: Recruiting

Location contact

Se Ri Bae, MD

CONTACT

[email protected]

916-244-0832

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Change in MADRS score

    Time frame: 1 week

    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.

Secondary outcomes

  1. Change in C-SSRS score

    Time frame: 1 week

    Change in suicidal ideations as measured by Columbia Suicide Severity Rating Scale (C-SSRS) from baseline to post-treatment. Suicidal ideation is assessed using a 5-point scale (range: 0-5), with higher scores indicating greater severity.

  2. Health utilization rate

    Time frame: 1 week, 1 month

    Rates of health visits at 1-week and 1 month follow-up

  3. Change in Q_LES_Q_SF score

    Time frame: 1 week and 1 month

    Change in functional impairment as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q_LES_Q_SF). Scores range from 14 to 70, with higher scores indicating better quality of life

Other outcomes

  1. Changes in Functional Connectivity

    Time frame: 1 week, 1 month

    To explore the changes in functional connectivity patterns associated with the antidepressant and anti-suicidal effects of the intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Se Ri (Sally) Bae, MD

CONTACT

[email protected]

213-340-4006

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Sorensen Foundation

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 17, 2025
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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