Major Depressive Disorder (MDD)NCT07025720
Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
A study testing TMS in people with Major Depressive Disorder (MDD) and Suicidal Ideation, run by University of California, Davis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Major Depressive Disorder (MDD), Suicidal Ideation
- What is being tested?
- TMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 31 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis Medical Center
Sacramento, California, 95817
Se Ri Bae, MD, 916-244-0832, sebae@health.ucdavis.edu
About this study
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:
Read more
- This treatment is feasible and acceptable to patients
- It can reduce depression and suicidal thoughts
- It can lower the chance of going to the hospital
- 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
- Being tested
- TMS
- Keywords
- TMS, MDD, Suicidal ideation, transcranial magnetic stimulation
- Medical subject headings
- Depressive Disorder, Major, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TMSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| TMS | Experimental | Not described Receives: Device: TMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (3)
Change in C-SSRS score
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.
Measured: 1 week
Health utilization rate
Rates of health visits at 1-week and 1 month follow-up
Measured: 1 week, 1 month
Change in Q_LES_Q_SF score
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
Measured: 1 week and 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025
- Primary completionApr 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Sorensen Foundation
- Responsible party
- Principal investigator, Se Ri (Sally) Bae, MD, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07025720
- Sponsor's protocol ID
- 2227384
- Status last verified
- Mar 2026
- First submitted
- 9 Jun 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Intermittent Theta Burst Stimulation for Adolescent and Young Adult Depression With Elevated Suicide Risk
- ClinicalTrials.gov ID
- NCT07025720
- Acronym / sponsor ID
- 2227384
- Conditions
- Major Depressive Disorder (MDD), Suicidal Ideation
- Keywords
- TMS, MDD, Suicidal ideation, transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Sorensen Foundation
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 17 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- This treatment is feasible and acceptable to patients
- It can reduce depression and suicidal thoughts
- It can lower the chance of going to the hospital
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMS | Experimental | Device: TMS |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TMSThe 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). | Device | TMS |
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TMS in people with Major Depressive Disorder (MDD) and Suicidal Ideation, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Se Ri (Sally) Bae, MD (213-340-4006, sebae@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in MADRS score (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.