WITHDRAWN

Rapid Acting TMS for Suicide Ideation in Depression

Conditions

Depressive Disorder, Major Suicide suicidality neuromodulation transcranial magnetic stimulation depression

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2021-11-07

Study Completion:2025-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:WITHDRAWN

Study ID

NCT05100004

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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). 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)	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).

Inclusion Criteria

Exclusion 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).
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)

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).

Contacts and Locations

Principal Investigator

David Spiegel, MD

PRINCIPAL_INVESTIGATOR

Stanford University

Study Locations (Sites)

Stanford Hospital

Stanford, California, 94305

United States

Collaborators and Investigators

Sponsor: Stanford University

David Spiegel, MD, PRINCIPAL_INVESTIGATOR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-07

Study Completion Date2025-09

Study Record Updates

Study Start Date2021-11-07

Study Completion Date2025-09

Terms related to this study

Keywords Provided by Researchers

suicidality
neuromodulation
transcranial magnetic stimulation
depression

Additional Relevant MeSH Terms

Depressive Disorder, Major
Suicide