Bilateral aTBS for Suicidal Ideation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UCSD Interventional Psychiatry, San Diego, CA
Suicidal Ideation+3 More
Accelerated Theta Burst Stimulation - Device
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This is a prospective clinical trial to confirm the effectiveness of bilateral accelerated theta burst stimulation (aTBS) on suicidal ideation (SI), while exploring cortical inhibition measures in this treatment paradigm. In this proposed study, the investigators will evaluate the anti-suicidal effects of bilateral aTBS over the DLPFC compared to accelerated intermittent theta burst stimulation (aiTBS) over the left DLPFC in participants with TRD and SI. Additionally, the investigators aim to identify neurophysiological targets through which bilateral aTBS induces remission of SI in TRD differentially from aiTBS.

Eligible Conditions

  • Suicidal Ideation
  • Treatment-resistant Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: 6-months

6-months
Categorical suicidal clinical outcomes
Changes in scores on the suicide scale index (SSI) from baseline
Neurophysiological measures of cortical inhibition, N100, short interval cortical inhibition, and cortical evoked activity

Trial Safety

Trial Design

2 Treatment Groups

Unilateral aiTBS
1 of 2
Bilateral aTBS
1 of 2
Active Control
Experimental Treatment

76 Total Participants · 2 Treatment Groups

Primary Treatment: Bilateral aTBS · No Placebo Group · N/A

Bilateral aTBS
Device
Experimental Group · 1 Intervention: Accelerated Theta Burst Stimulation · Intervention Types: Device
Unilateral aiTBS
Device
ActiveComparator Group · 1 Intervention: Accelerated Theta Burst Stimulation · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6-months

Trial Background

Prof. Cory Weissman, Medical Head Interventional Psychiatry; Assistant Clinical Professor of Psychiatry
Principal Investigator
University of California, San Diego
Closest Location: UCSD Interventional Psychiatry · San Diego, CA
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N/AFirst Recorded Clinical Trial
1 TrialsResearching Suicidal Ideation
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
Pass the TMS adult safety screening (TASS) questionnaire and the MRI safety screening questionnaire.
You have a general medical condition (GMC) that has been ruled out during initial assessment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.