Your session is about to expire
← Back to Search
Non-invasive Brain Stimulation
Accelerated Theta Burst Stimulation for Suicidal Thoughts (COMBAT-SI Trial)
N/A
Recruiting
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 18-70 years old
Psychiatric illness due to a general medical condition (GMC) has been ruled out during initial assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-months
Awards & highlights
COMBAT-SI Trial Summary
This trial will test two different types of brain stimulation to see which is more effective at reducing suicidal thoughts in people with treatment-resistant depression.
Who is the study for?
This trial is for adults aged 18-70 with major depression and ongoing suicidal thoughts, who haven't responded to at least two antidepressants. Participants must pass safety screenings for transcranial magnetic stimulation (TMS) and MRI, be outpatient-capable, and not have severe medical or neurological conditions. Pregnant women or those unable to use birth control are excluded.Check my eligibility
What is being tested?
The study tests the effectiveness of accelerated Theta Burst Stimulation (aTBS), a type of TMS therapy on suicidal ideation in people with treatment-resistant depression. It compares bilateral aTBS over the DLPFC region of the brain versus aiTBS over just the left side.See study design
What are the potential side effects?
Potential side effects may include discomfort at stimulation site, headache, lightheadedness, seizures (rare), hearing problems if ear protection isn’t used during treatment, and temporary changes in thinking or mood.
COMBAT-SI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
Select...
My mental health issues are not caused by another medical condition.
Select...
I have been diagnosed with a major depressive episode and my depression is severe.
COMBAT-SI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6-months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in scores on the suicide scale index (SSI) from baseline
Secondary outcome measures
Categorical suicidal clinical outcomes
Neurophysiological measures of cortical inhibition, N100, short interval cortical inhibition, and cortical evoked activity
COMBAT-SI Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bilateral aTBSExperimental Treatment1 Intervention
Patients will receive Bilateral accelerated theta-burst stimulation bilaterally for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions.
Group II: Unilateral aiTBSActive Control1 Intervention
Patients will receive unilateral accelerated theta-burst stimulation to the left side for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions. There will be a right DLPFC sham component to this treatment arm for all treatment sessions.
Find a Location
Who is running the clinical trial?
Brain & Behavior Research FoundationOTHER
61 Previous Clinical Trials
2,738 Total Patients Enrolled
19 Trials studying Depression
1,059 Patients Enrolled for Depression
University of California, San DiegoLead Sponsor
1,121 Previous Clinical Trials
1,521,349 Total Patients Enrolled
29 Trials studying Depression
56,102 Patients Enrolled for Depression
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with OCD, PTSD, anxiety, or dysthymia that affects me more than my depression.I have been diagnosed with a major depressive episode and my depression is severe.I am unable to consent to treatment or not suitable for outpatient care.I am between 18 and 70 years old.I am not pregnant, breastfeeding, and if I can have children, I use birth control.I have been diagnosed with a serious mental health condition like bipolar disorder or schizophrenia.My mental health issues are not caused by another medical condition.I have tried two antidepressants without success or could not tolerate them.I take more than 2 mg of lorazepam daily or any amount of seizure medication.I have been diagnosed with a major depressive episode and my depression is severe.I can make my own health decisions and am being treated at UC San Diego Health's Psychiatry program.I do not have any major unstable illnesses or metal implants in or near my head that can't be removed.You are currently experiencing ongoing suicidal thoughts, as confirmed by a screening test called the Beck SSI score.
Research Study Groups:
This trial has the following groups:- Group 1: Unilateral aiTBS
- Group 2: Bilateral aTBS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How extensive is the participant pool for this medical experiment?
"Affirmative. According to the clinicaltrials.gov listing, this experiment is still recruiting applicants, having been first posted on September 2nd 2022 and last revised on the 9th of that same month. 76 people are needed for this study at a single site."
Answered by AI
Does this experiment offer participation to those of advanced age?
"Qualifying participants must be between 18 and 70 years old; there are 197 trials lining up patients that are younger than the age of majority, while 901 studies will accept volunteers over retirement age."
Answered by AI
Who is qualified to be a participant in this research?
"In order to be eligible for this clinical trial, potential participants have to experience suicidal thoughts and must fit within the age range of 18-70. Currently, 76 people are required for successful completion of this study."
Answered by AI
Is this experiment recruiting participants presently?
"Affirmative. The details published on clinicaltrials.gov reveal that this research project has open positions for enrollment. It was first posted on the 2nd of September 2022, with a recent update taking place on 9th of September 2022, and it is search to recruit 76 individuals at one medical facility."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
What site did they apply to?
UCSD Interventional Psychiatry
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
Why did patients apply to this trial?
I have not been able to stop SI.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
How long am I required to be in San Diego?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Most responsive sites:
- UCSD Interventional Psychiatry: < 24 hours
Average response time
- < 1 Day
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger