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NCT05377177 · ClinicalTrials.gov registry record · NA
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
A NA study of Suicidal Ideation and Treatment-Resistant Depression, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- NA
- Development phase
- 76
- Enrollment target
- 1
- Study location
NCT05377177: Recruiting NA study of Suicidal Ideation and Treatment-Resistant Depression, sponsored by University of California, San Diego.
NCT05377177 is a NA study of Suicidal Ideation and Treatment-Resistant Depression that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 76 participants, below the 267-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05377177, a NA study of Suicidal Ideation and Treatment-Resistant Depression, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- NA
- Development phase
- 76 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The primary outcome will be a comparison of change in score on the suicidality scale index (SSI) from baseline to endpoint of treatment between accelerated bilateral and unilateral treatment. The SSI contains 19 items scored from 0 to 2, higher scores indicating more severity, with overall scores ranging from 0 to 38The primary endpoint will be at treatment completion for both arms. The investigators will follow patients at 1, 2, 3, and 4 weeks post-treatment, as well as 3 and 6 months after tre
Conditions Studied
Interventions
- DEVICE Accelerated Theta Burst Stimulation
Study Locations (1)
California
- UCSD Interventional Psychiatry - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2022-09-02 |
| Est. Completion | 2030-07-30 |
| Phase | NA |
What NCT05377177 shows while recruiting
NCT05377177 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 267-participant average among 84 other Suicidal Ideation trials with a reported enrollment target (72% lower).
The record links to 2 conditions, with Suicidal Ideation appearing as the primary indexed condition, and to 1 intervention - of which Accelerated Theta Burst Stimulation is the first listed.
NCT05377177 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05377177 about?
NCT05377177 is a clinical study titled "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". 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 effe...
What is the current status of trial NCT05377177?
This trial is currently recruiting. It is a NA study. The enrollment target is 76 participants. The study started on 2022-09-02. Estimated completion is 2030-07-30.
What conditions does trial NCT05377177 study?
This clinical trial studies the following conditions: Suicidal Ideation, Treatment-Resistant Depression.
What interventions are being tested in trial NCT05377177?
The interventions under investigation include: Accelerated Theta Burst Stimulation (DEVICE).
Who is sponsoring clinical trial NCT05377177?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05377177 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05377177's enrollment target sits among peer trials
76 53rd of 84 higher than 32 of 84 other Suicidal Ideation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Suicidal Ideation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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