Rapid Acting TMS for Suicide Ideation in Depression

Launched by STANFORD UNIVERSITY · Oct 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called accelerated intermittent theta-burst stimulation (aiTBS) to see how it can help reduce thoughts of suicide in people suffering from major depressive disorder. The goal is to understand how this treatment affects the brain's connections related to suicidal thoughts. If you or someone you know is between the ages of 22 and 65, has been diagnosed with major depressive disorder or specific types of bipolar disorder, and is currently experiencing suicidal thoughts, you might be eligible to participate in this study.

Participants in the trial will receive aiTBS treatment while staying in the hospital and will be closely monitored by healthcare professionals. To join, individuals must not have had previous exposure to TMS (transcranial magnetic stimulation) and should be in generally good health. The study has specific requirements, such as not being pregnant and having no history of certain medical conditions like seizures or severe cognitive impairment. Participants will also need to agree to use contraception if they are capable of becoming pregnant. Overall, this trial is an important step in finding new ways to help those struggling with severe depression and suicidal thoughts.

Gender

ALL

Eligibility criteria

• 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).