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Rapid Acting TMS for Suicide Ideation in Depression
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.
Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression
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
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
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