Cortical Inhibition as a Biomarker of Response in a Comparison of Bilateral Versus Unilateral Accelerated Theta Burst Stimulation for Suicidal Ideation in Treatment-Resistant Depression -COMBAT-SI

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT05377177
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Accelerated Theta Burst Stimulation — DEVICE
    B65 magnetic coil stimulation applied to the dorsal lateral prefrontal cortex.

Study Details

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.

Key Dates

Start date
Sep 2, 2022
Status verified
Nov 2025
Primary completion
Aug 1, 2029
Completion
Jul 30, 2030

Study Design

Enrollment
76 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Bilateral aTBS
    Patients will receive Bilateral accelerated theta-burst stimulation bilaterally for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions.
  • Active Comparator: Unilateral aiTBS
    Patients will receive unilateral accelerated theta-burst stimulation to the left side for 5 consecutive days, with a total of 10 hours a day. treatment will be 10min with 50min of breaks in between the 10 sessions. There will be a right DLPFC sham component to this treatment arm for all treatment sessions.

Primary Outcome Measure

Changes in scores on the suicide scale index (SSI) from baseline [ Time Frame: 6-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Interventional PsychiatrySan DiegoCalifornia92127
Interventional Psychiatry
[email protected]
(858) 207-0938

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
UCSD Interventional Psychiatry· San Diego, CA

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