Rapid Acting TMS for Suicide Ideation in Depression


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Trial ID: NCT05100004


This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed accelerated intermittent theta-burst stimulation (aiTBS), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.

Official Title

Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression

Stanford Investigator(s)

David Spiegel
David Spiegel

Jack, Lulu and Sam Willson Professor of Medicine


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

   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

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

   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

   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).


device: Accelerated Theta Burst Stimulation

device: Sham Stimulation


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Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jean-Marie Batail, MD, PhD