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NCT07680153 · ClinicalTrials.gov registry record · Phase 4
Neuromodulation of Mood Switch Circuitry in Bipolar Disorder
A Phase 4 study, sponsored by Weill Medical College of Cornell University.
- Not yet
- Registry status
- Phase 4
- Development phase
- 62
- Enrollment target
NCT07680153: Clinical Trial Phase 4 study, sponsored by Weill Medical College of Cornell University.
NCT07680153 is a Phase 4 study that has not yet begun recruiting, run by Weill Medical College of Cornell University. The registered enrollment target is 62 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07680153, a Phase 4 study, has not yet begun recruiting, sponsored by Weill Medical College of Cornell University.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 62 participants
- Enrollment target
Study Summary
This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD. Investigators in this study will use a technique called repetitive transcranial magnetic stimulation, or rTMS. It uses non-invasive magnetic pulses delivered to the scalp to stimulate specific areas of the brain. rTMS is already used to treat depression, and investigators are now studying whether it can be made even more effective for people with bipolar disorder by precisely targeting an individualized brain region for each participant. Participants in this study will receive two courses of rTMS, one active and one placebo (called "sham"), in a randomized order so investigators can directly compare the effects. Before treatment, investigators will use brain scans (MRI) to create a personalized map of each participant's brain activity. This lets investigators identify the exact stimulation target most likely to influence the brain circuits involved in BD mood shifts. Investigators will track mood symptoms closely throughout the study to measure what changes. Investigators believe that depression in BD is partly driven by disrupted communication between two brain regions involved in processing what feels important or rewarding. Investigators want to find out whether rTMS can restore that communication and whether doing so leads to measurable improvements in depression.
Primary Outcome
Within-participant difference in change in depression, measured by score on the Montgomery-Asberg Depression Rating Scale (MADRS), in the active intervention phase vs. the sham intervention phase. The minimum MADRS score is 0 and the maximum MADRS score is 60, with higher scores indicating greater depression severity. The primary analysis uses a linear mixed-effects model with fixed effects for time (pre/post), condition (active/sham), intervention phase, and randomization sequence, with a subje
Interventions
- DEVICE Sham Stimulation
- DEVICE MagVenture MagPro TMS system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2026-07 |
| Est. Completion | 2031-12 |
| Phase | Phase 4 |
What is known before NCT07680153 opens enrollment
NCT07680153 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 62 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham Stimulation is the first listed.
NCT07680153 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07680153 about?
NCT07680153 is a clinical study titled "Neuromodulation of Mood Switch Circuitry in Bipolar Disorder". This study is exploring a new approach to treating depression in people with bipolar disorder (BD). Investigators are testing whether a non-invasive form of brain stimulation can help us understand depressed-to-euthymic mood shifts and their related brain circuits in BD. Investigators in this study...
What is the current status of trial NCT07680153?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 62 participants. The study started on 2026-07. Estimated completion is 2031-12.
What interventions are being tested in trial NCT07680153?
The interventions under investigation include: Sham Stimulation (DEVICE), MagVenture MagPro TMS system (DEVICE).
Who is sponsoring clinical trial NCT07680153?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07680153's enrollment target sits among peer trials
62 1110th of 2000 higher than 882 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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