Brain zaps show promise against suicidal thoughts in depression
NCT ID NCT05377177
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a non-invasive brain stimulation technique called accelerated theta burst stimulation to reduce suicidal thoughts in people with treatment-resistant depression. About 76 adults will receive either bilateral or unilateral stimulation to see which works better. The goal is to quickly ease suicidal thinking and find brain markers that predict who responds best.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Jul 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
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A doctor treating you
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Contacts and locations
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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UCSD Interventional Psychiatry
RECRUITINGSan Diego, California, 92127, United States
Contact Email: •••••@•••••
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Other studies related to the condition(s) this trial covers.
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