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| Name | Class |
|---|---|
| Sorensen Foundation | UNKNOWN |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TMS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in MADRS score | Change in depressive symptoms as measured by The Montgomery-Ã…sberg 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
| Health utilization rate |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Functional Connectivity | To explore the changes in functional connectivity patterns associated with the antidepressant and anti-suicidal effects of the intervention | 1 week, 1 month |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Se Ri (Sally) Bae, MD | Contact | 213-340-4006 | sebae@ucdavis.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center | Recruiting | Sacramento | California | 95817 | United States |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D059020 | Suicidal Ideation |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D013405 | Suicide |
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Rates of health visits at 1-week and 1 month follow-up |
| 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 | 1 week and 1 month |
| D016728 |
| Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |