Comparing two types of brain stimulation for reducing suicidal thoughts in patients with treatment-resistant depression

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)

This study is testing two types of brain stimulation to see which one helps reduce suicidal thoughts in people with treatment-resistant depression.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 76 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: University of California, San Diego (other)
• Locations: 1 site (San Diego, California)
• Trial ID: NCT05377177 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation in patients with treatment-resistant depression (TRD). Participants will receive either bilateral aTBS or accelerated intermittent theta burst stimulation (aiTBS) targeted at specific areas of the brain. The study will also explore how changes in cortical inhibition relate to the treatment's effectiveness. By comparing these two stimulation methods, the researchers hope to identify the most effective approach for alleviating suicidal thoughts.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-70 with a diagnosis of major depressive episode and ongoing suicidal ideation who have not responded to previous antidepressant treatments.

Not a fit: Patients who do not have treatment-resistant depression or those with psychiatric illness due to a general medical condition may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel and effective treatment option for patients suffering from treatment-resistant depression and suicidal ideation.

How similar studies have performed: Previous studies have shown promising results for brain stimulation techniques like rTMS in treating suicidal ideation, suggesting that this approach may be effective.

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 (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.

Where this trial is running

San Diego, California

• UCSD Interventional Psychiatry — San Diego, California, United States (RECRUITING)

Study contacts

• Study coordinator: Interventional Psychiatry

Conditions: Suicidal Ideation, Treatment-resistant Depression, theta burst stimulation, accelerated TBS, bilateral TBS