Personalized Accelerated Intermittent Theta Burst Stimulation for Post-Acute Suicidal Ideation

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder (MDD); Suicidal Ideation

• Registration Number: NCT07025720
• Lead Sponsor: University of California, Davis

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 patients who recently went to the hospital for suicidal thoughts and were sent home.

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 returning to the hospital

4. It affects daily functioning (school, work, relationships)

All participants will undergo 5-days of TMS treatment within 1 week of leaving the hospital. All participants will complete MRI brain scans before and after treatment. They will return for check-ups after 1 week and 4 weeks.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-09
• Study First Submitted QC: 2025-06-09
• Last Update Submitted: 2025-06-16
• Study First Posted: 2025-06-17
• Last Update Posted: 2025-06-19
• Study Start: 2025-07-01
• Primary Completion: 2027-04
• Study Completion: 2027-05-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• English speaking
• Able to provide informed consent
• ≥ 15 years old
• Discharged within the past week from the ED for chief complaint of SI
• MDD criteria per the Mini International Neuropsychiatric Interview (MINI)

Exclusion Criteria

• Unable to consent (due to medical condition, psychosis, substance use, etc)
• Active use of benzodiazepines or medications that would interfere with treatment with TMS 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
• Dementia as documented in medical records
• Bipolar disorder as determined by the MINI
• Contraindications to receiving TMS and/or MRI as determined by screening questionnaires
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in MADRS score	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 Outcome Measures

Name	Time	Method
Change in C-SSRS score	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.
Hospital readmission rate	1 week, 1 month	Hospital admissions for suicidal ideations or depression at 1-week and 1 month follow-up
Change in FAST score	1 week and 1 month	Change in functional impairment as measured by the Functional Assessment Short Test (FAST). Scores range from 0 to 72, with higher scores indicating greater functional impairment.