Rapid Acting TMS for Suicide Ideation in Depression

September 25, 2025 updated by: David Spiegel, Stanford University

Rapid Acting Transcranial Magnetic Stimulation for Suicide Ideation in Depression

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford Hospital

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Left Dorsolateral Prefrontal Cortex (L-DLPFC)
The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC)
Device: Accelerated Theta Burst Stimulation

Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered using the Magventure Magpro X100 TMS system.
Sham Comparator: Sham Stimulation
Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region
Device: Sham Stimulation

Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.

Sham stimulation will be delivered using the Magventure Magpro X100 TMS system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).
Time Frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
The modified Scale for Suicide (m-SSI) is an 18-item clinician rated scale that measures suicidal ideation. Each item is scored from 0-3. Scores are summed for 1 total score. Higher scores indicate more severe suicidal ideation. Investigators will assess change in m-SSI scores at the post-inpatient treatment completion (day 2-7).
At baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time Frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)

The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

Remission is defined as MADRS ≤10.
At baseline (day 0) and at post-inpatient treatment completion (day 2-7)
Rates of response immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.
Time Frame: At baseline (day 0) and at post-inpatient treatment completion (day 2-7)

The Montgomery-Åsberg Depression Rating Scale (MADRS), is a ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression, and each item yields a score of 0 to 6. The overall score ranges from 0 to 60.

Response is defined as a reduction of >/=50% of MADRS baseline score.
At baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: David Spiegel, MD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

November 7, 2021

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

October 19, 2021

First Posted (Actual)

October 29, 2021

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 58808

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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