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NCT05537285 · ClinicalTrials.gov registry record · NA
Individualized Neuromodulation for Anhedonic Depression
A NA study, sponsored by University of California, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT05537285: Completed NA study, sponsored by University of California, San Diego.
NCT05537285 is a NA study that has completed, run by University of California, San Diego. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05537285, a NA study, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study Summary
This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with the overarching goals to compare competing interventions tested at each site and to combine data that will allow for the creation of an end-to-end model of anhedonic depression. By doing this, the investigators hope to gain insight and lead to the development of brain-behavior biomarkers to identify who is best suited for the different treatment options tested at each site. An additional exploratory objective is phenotyping anhedonic depression from the acquired measures. Anhedonic patients recruited at UCSD will be randomized to one of three treatment arms to receive different forms of accelerated intermittent theta burst stimulation (aiTBS),a novel form of repetitive transcranial magnetic stimulation (rTMS) that is an FDA approved treatment for depression. These arms include: individualized accelerated iTBS (Ind-aiTBS),based on both the frequency of brain responses and electric-field (e-field) modeling of brain bioconductivity; standard accelerated iTBS (Std-aiTBS); and accelerated sham iTBS(sham). Treatment will be delivered on an accelerated schedule, over one week. Additional study sessions will occur both before and after treatment to assess for clinical, neurophysiological, and cognitive measures that will allow for both individualization of treatment and detailed assessment of the effects of the different treatment arms.
Primary Outcome
To evaluate the effects of individualized accelerated iTBS (using BOTH the frequency and e-field individualization; Ind-aiTBS) compared to standard accelerated iTBS (Std-aiTBS) and sham accelerated iTBS (sham) on depression severity measured with the Montgomery- Asbery Depression Rating Scale (MADRS).
Interventions
- DEVICE Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS)
- DEVICE Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS)
- DEVICE Sham Accelerated Intermittent Theta Burst Stimulation (Sham)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-08-01 |
| Est. Completion | 2025-05-30 |
| Phase | NA |
What the finished NCT05537285 record still lists
NCT05537285 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 3 interventions - of which Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) is the first listed.
NCT05537285 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05537285 about?
NCT05537285 is a clinical study titled "Individualized Neuromodulation for Anhedonic Depression". This program of research constitutes a three-arm, randomized, placebo-controlled trial testing noninvasive brain stimulation for the treatment of anhedonic depression. This trial is part of a larger, three-site study that will be conducted at UCSD, Stanford University, and Cornell University, with t...
What is the current status of trial NCT05537285?
This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2022-08-01. Estimated completion is 2025-05-30.
What interventions are being tested in trial NCT05537285?
The interventions under investigation include: Individualized Accelerated Intermittent Theta Burst Stimulation (Ind-aiTBS) (DEVICE), Standard Accelerated Intermittent Theta Burst Stimulation (Std-aiTBS) (DEVICE), Sham Accelerated Intermittent Theta Burst Stimulation (Sham) (DEVICE).
Who is sponsoring clinical trial NCT05537285?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05537285's enrollment target sits among peer trials
60 1164th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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