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)
University of California, San Diego
Summary
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.
Description
Suicidality is a growing epidemic, as over 700,000 people die by suicide around the world annually. Current treatments for suicidality are limited and novel treatments for suicidality are desperately needed. There is early evidence to suggest that the non-invasive brain stimulation treatment called repetitive transcranial magnetic stimulation, or rTMS, is better than placebo at eliminating suicidal ideation (SI) in patients with hard to treat depressive illness (treatment-resistant depression; TRD). The UCSD Interventional Psychiatry lab was the first group to demonstrate that bilateral rTMS,…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceAccelerated Theta Burst Stimulation
B65 magnetic coil stimulation applied to the dorsal lateral prefrontal cortex.
Location
- UCSD Interventional PsychiatrySan Diego, California