NCT05377177 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
| NCT ID | NCT05377177 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, San Diego |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 76 participants |
| Start Date | 2022-09-02 |
| Primary Completion | 2029-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 76 participants in total. It began in 2022-09-02 with a primary completion date of 2029-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05377177 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05377177 currently recruiting?
Yes, NCT05377177 is actively recruiting participants. Contact the research team at iptrials@health.ucsd.edu for enrollment information.
Where is the NCT05377177 trial being conducted?
This trial is being conducted at San Diego, United States.
Who is sponsoring the NCT05377177 clinical trial?
NCT05377177 is sponsored by University of California, San Diego. The trial plans to enroll 76 participants.