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Rapid Acting TMS for Suicide Ideation in Depression | Clinical Trials | Clareo Health

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Rapid Acting TMS for Suicide Ideation in Depression

Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression

NCT05100004•Stanford University

Summary

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.

Detailed Description

Investigators recently developed a form of neuromodulation termed Stanford Neuromodulation Therapy (SNT). SNT-induced remission is associated with significant reductions in the functional connectivity of the neural network underlying explicit suicidal cognition (between sgACC-DMN). This project aims to further elucidate the SNT induced neural network changes underlying explicit suicidal cognition.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+2 more criteria

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
+12 more criteria

Locations (1)

Stanford Hospital

Stanford, California, United States

Key Dates

Start Date

November 7, 2021

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2025

Last Updated

September 29, 2025

Conditions

Depressive Disorder, MajorSuicide

Interventions

Accelerated Theta Burst Stimulation

DEVICE

Sham Stimulation

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rapid Acting TMS for Suicide Ideation in Depression

Inclusion Criteria

Exclusion Criteria

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