Brain zaps for suicide prevention? study pulled before starting
NCT ID NCT05100004
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to see if a fast-acting form of brain stimulation (called accelerated TMS) could change brain activity linked to suicidal thinking in adults hospitalized for major depression. The researchers planned to measure changes in suicidal thoughts using a standard questionnaire. However, the study was withdrawn before enrolling any participants, so no results are available.
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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.
- Started
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Nov 2021
- Expected to finish
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Sep 2025
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 75 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.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 22-65 year old at the time of screening on voluntary or involuntary hold 2. Able to read, understand, and provide written, dated informed consent prior to screening. Participants will be deemed likely to comply with study protocol and communicate with study personnel about adverse events and other clinically important information. 3. Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPD II), according to the criteria defined in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5). Endorse suicidal ideation (score ≥9 on the SSI-M). 4. Meet the threshold on the MADRS and HAMD-17 with a total score of \>/=20 at baseline. 5. Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI) 6. Have to be TMS naive 7. In good general health, as ascertained by medical history. 8. Scheduled with a psychiatrist 9. Access to clinical rTMS after hospital discharge 10. If participant is of childbearing potential and not already pregnant, must agree to use adequate contraception prior to study and for the duration of study participation. 11. No recent use (for the actual depressive episode) of rapid acting antidepressive agent (ketamine) Exclusion Criteria: 1. Any abnormalities indicated on previous MRI scans e.g. structural neurological condition, more subcortical lesions than would be expected for age, stroke affecting stimulated area or connected areas or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results. 2. Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear 3. History of epilepsy/ seizures (including history of withdrawal/ provoked seizures) 4. Shrapnel or any ferromagnetic item in the head. 5. Pregnancy: The effects of rTMS on the developing human fetus are incipient and still uncertain (25). Pregnant women will not be enrolled into this study. Women of childbearing potential must agree to use adequate contraception (hormonal / barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Females of childbearing-age, will have a pregnancy test prior to receiving each rTMS stimulation session. Should a woman become pregnant or suspects she is pregnant while participating in this study, she should inform study staff. 6. Autism Spectrum disorder 7. A diagnosis of obsessive-compulsive disorder (OCD) 8. The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia 9. Any current or past history of any physical condition which in the investigator's opinion might put the subject at risk or interfere with study results interpretation. 10. Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines 11. Cognitive impairment (including dementia) 12. Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation) 13. Current mania or psychosis 14. Bipolar Affective Disorder I and primary psychotic disorders. 15. Showing symptoms of withdrawal from alcohol or benzodiazepines 16. IQ\<70 17. Parkinsonism or other movement d/o determined by PI to interfere with treatment 18. Desirous of getting ECT and previous intolerant exposure to ECT 19. Any other indication the PI feels would comprise data 20. No access to clinical rTMS after discharge. 21. Previous TMS exposure. 22. Depth-adjusted aiTBS treatment dose \> 65% maximum stimulator output (MSO).
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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.
Contacts and locations
Locations
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Stanford Hospital
Stanford, California, 94305, United States
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Other studies related to the condition(s) this trial covers.
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