Recruiting

TMS

Sponsor:

UCLA

Code:

NCT07025720

Conditions

Major Depressive Disorder (MDD)

Suicidal Ideation

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

Interventions

TMS

Study Details

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. 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.

Conditions

Major Depressive Disorder (MDD)

Suicidal Ideation

Study ID

NCT07025720

Start date

Jul 1, 2025

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 25

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: TMS

Interventions

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 measure

  • Change in MADRS score [ Time Frame: 1 week ]

Central Contacts and Locations

Central contacts

Se Ri (Sally) Bae, MD

213-340-4006sebae@ucdavis.edu

Locations

UC Davis Medical Center

Recruiting

Sacramento, California, United States, 95817

Contacts

Se Ri Bae, MD

916-244-0832sebae@health.ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Keywords

  • TMS
  • MDD
  • Suicidal ideation
  • transcranial magnetic stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-03-11.