Bilateral Theta Burst Stimulation for Depression and Suicidal Thoughts
Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 70
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
76 (estimated)
Sponsor
University of California, San Diego · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 70 who have treatment-resistant depression and are experiencing suicidal thoughts. Participants will receive a specialized brain stimulation treatment and undergo assessments to measure its effects on their symptoms.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 70 years old.
I have been diagnosed with a major depressive episode.
I have ongoing suicidal thoughts.
I have not responded to two antidepressants.
I can provide consent for treatment.
I can follow the treatment schedule.
You may not be able to join if
I have a substance use disorder in the last 3 months.
I have been diagnosed with bipolar disorder or schizophrenia.
I have a major anxiety disorder or PTSD.
I am currently pregnant or breastfeeding.
I have a serious brain condition or metal implants in my head.
I am unable to consent to treatment.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI), while exploring cortical inhibition measures in this treatment paradigm. In this proposed study, the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation (a…
This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI), while exploring cortical inhibition measures in this treatment paradigm. In this proposed study, the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation (aiTBS) over the left DLPFC in participants with TRD and SI. Additionally, the investigators aim to identify neurophysiological targets through which bilateral aTBS induces remission of SI in TRD differentially from aiTBS.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 18-70 years old.
2. Diagnosis of major depressive episode, confirmed on Mini-International Neuropsychiatric Interview (MINI), with HRSD score ≥18.
3. Ongoing SI present beyond screening phase of study (confirmed with Beck SSI score ≥4).
4. Pass the TMS adult safety screening …
Inclusion Criteria:
1. 18-70 years old.
2. Diagnosis of major depressive episode, confirmed on Mini-International Neuropsychiatric Interview (MINI), with HRSD score ≥18.
3. Ongoing SI present beyond screening phase of study (confirmed with Beck SSI score ≥4).
4. Pass the TMS adult safety screening (TASS) questionnaire and the MRI safety screening questionnaire.
5. Have failed to achieve a clinical response to an adequate dose of two antidepressants based on an Antidepressant Treatment History Form (ATHF) score for each antidepressant trial of \> 3 in the current episode OR have been unable to tolerate at least 2 separate trials of antidepressants of inadequate dose and duration (ATHF score of 1 or 2 on those 2 separate antidepressants) OR have a combination of one failed trial and one not tolerated trial, per the definitions above.
6. Psychiatric illness due to a general medical condition (GMC) has been ruled out during initial assessment.
7. Voluntary outpatients capable to consent to treatment and seen at the UC San Diego Health Interventional Psychiatry program.
8. Able to adhere to the treatment schedule.
Exclusion Criteria:
1. Have a confirmed diagnosis of substance use disorder within the last 3 months.
2. Have a lifetime diagnosis of bipolar I or II disorder, schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder, or current psychotic symptoms.
3. Have a diagnosis of obsessive compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia, that is assessed by a study investigator to be primary and causing greater impairment than MDD.
4. Have a diagnosis of any personality disorder, and assessed by a study investigator to be primary and causing greater impairment than MDD.
5. Have SI prompting emergent involuntary hospital stay (SI in which the participant can maintain voluntary and capable outpatient status as well as recent suicide attempt will not be exclusionary).
6. Currently pregnant or lactating, or woman or childbearing age without adequate birth control.
7. Non-correctable clinically significant sensory impairment (i.e., cannot hear well enough to cooperate with interview).
8. Not capable to consent to treatment and/or not suitable for outpatient treatment.
9. Have a concomitant major unstable medical illness, cardiac pacemaker or implanted medication pump; Have any significant neurological disorder or insult including, but not limited to: any condition likely to be associated with increased intracranial pressure, space occupying brain lesion, any history of seizure except those therapeutically induced by ECT or a febrile seizure of infancy, cerebral aneurysm, Parkinson's disease, Huntington's chorea, multiple sclerosis, significant head trauma with loss of consciousness for greater than 5 minutes; Have an intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
10. Currently take more than lorazepam 2 mg daily (or equivalent) or any dose of an anticonvulsant due to the potential to limit rTMS efficacy.
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