Rapid Acting TMS for Suicide Ideation in Depression

NCT05100004 | Withdrawn DMC FDA Device

• 1 other identifier: 58808
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Disorder, Major; Suicide

Keywords

suicidality; neuromodulation; transcranial magnetic stimulation; depression

Outcome Measures

Primary Outcomes (1)

• Change in suicidal ideation as measured by the modified Scale for Suicide Ideation (m-SSI).

  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 Outcomes (2)

• Rates of remission immediately after treatment in the Montgomery-Åsberg Depression Rating Scale (MADRS) score.

  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.

  At baseline (day 0) and at post-inpatient treatment completion (day 2-7)

Study Arms (2)

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

ACTIVE COMPARATOR

The accelerated theta burst stimulation protocol will be applied to the left dorsolateral prefrontal cortex (DLPFC)

Device: Accelerated Theta Burst Stimulation

Sham Stimulation

SHAM COMPARATOR

Sham (non-active) stimulation will be applied to the left dorsolateral prefrontal cortex (DLPFC) region

Device: Sham Stimulation

Interventions

Accelerated Theta Burst Stimulation DEVICE

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.

Left Dorsolateral Prefrontal Cortex (L-DLPFC)

Sham Stimulation DEVICE

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.

Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22-65 year old at the time of screening on voluntary or involuntary hold
• 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.
• 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).
• Meet the threshold on the MADRS and HAMD-17 with a total score of \>/=20 at baseline.
• Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI)
• Have to be TMS naive
• In good general health, as ascertained by medical history.
• Scheduled with a psychiatrist
• Access to clinical rTMS after hospital discharge
• 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.
• No recent use (for the actual depressive episode) of rapid acting antidepressive agent (ketamine)

You may not qualify if:

• 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.
• Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
• History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)
• Shrapnel or any ferromagnetic item in the head.
• 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.
• Autism Spectrum disorder
• A diagnosis of obsessive-compulsive disorder (OCD)
• The presence or diagnosis of prominent anxiety disorder, personality disorder, or dysthymia
• 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.
• Active substance use (\<1 week) or intoxication verified by toxicology screen--of cocaine, amphetamines, benzodiazepines
• Cognitive impairment (including dementia)
• Current severe insomnia (must sleep a minimum of 5 hours the night before stimulation)
• Current mania or psychosis
• Bipolar Affective Disorder I and primary psychotic disorders.
• Showing symptoms of withdrawal from alcohol or benzodiazepines

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Stanford, California, 94305, United States

Location

Related Publications (14)

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MeSH Terms

Conditions

Depressive Disorder, Major; Suicide; Suicidal Ideation; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• David Spiegel, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Psychiatry and Behavioral Sciences, Stanford School of Medicine

Model Details: Patients will receive either active or sham stimulation to the DLPFC. Patients will be randomized to either condition with a 50:50 chance.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: October 29, 2021
• Study Start: November 7, 2021
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)