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NCT07127913 · ClinicalTrials.gov registry record · NA
Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression
A NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive, sponsored by Andrew Krystal.
- Recruiting
- Registry status
- NA
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT07127913: Recruiting NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive, sponsored by Andrew Krystal.
NCT07127913 is a NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive that is actively recruiting participants, run by Andrew Krystal. The registered enrollment target is 10 participants, below the 82-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07127913, a NA study of Bipolar II Disorder and Bipolar II Disorder, Most Recent Episode Major Depressive, is actively recruiting participants, sponsored by Andrew Krystal.
- RECRUITING
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to help alter the communication between groups of neurons in the brain. The purpose of this study is to test a personalized approach to brain stimulation as an intervention for bipolar depression The study researchers will use a surgically implanted device to measure each individual's brain activity related to his/her depression. The researchers will then use small electrical impulses to alter that brain activity and measure whether these changes help reduce depression symptoms. This study is intended for patients with major depression whose symptoms have not been adequately treated with currently available therapies. The device used in this study is called the NeuroPace Responsive Neurostimulation (RNS) System. It is currently FDA approved to treat patients with epilepsy. The study will test whether personalized responsive neurostimulation can safely and effectively treat bipolar depression.
Primary Outcome
Effect size comparing closed-loop stimulation, open-loop (fixed intermittent) stimulation, and sham stimulation (MADRS score before and after each treatment period of the crossover). Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.
Conditions Studied
Interventions
- DEVICE Device: Stimulation-ON
- DEVICE Device: Stimulation-OFF
- DEVICE Device: Stimulation -ON Active Control
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-07-16 |
| Est. Completion | 2035-06-28 |
| Phase | NA |
What NCT07127913 shows while recruiting
NCT07127913 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 82-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (88% lower).
The record links to 2 conditions, with Bipolar II Disorder appearing as the primary indexed condition, and to 3 interventions - of which Device: Stimulation-ON is the first listed.
NCT07127913 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT07127913 about?
NCT07127913 is a clinical study titled "Closed-Loop Deep Brain Stimulation for Treatment-Resistant Bipolar Depression". Neurons are specialized types of cells that are responsible for carrying out the functions of the brain. Neurons communicate with electrical signals. In diseases such as major depression this electrical communication can go awry. One way to change brain function is using electrical stimulation to he...
What is the current status of trial NCT07127913?
This trial is currently recruiting. It is a NA study. The enrollment target is 10 participants. The study started on 2025-07-16. Estimated completion is 2035-06-28.
What conditions does trial NCT07127913 study?
This clinical trial studies the following conditions: Bipolar II Disorder, Bipolar II Disorder, Most Recent Episode Major Depressive.
What interventions are being tested in trial NCT07127913?
The interventions under investigation include: Device: Stimulation-ON (DEVICE), Device: Stimulation-OFF (DEVICE), Device: Stimulation -ON Active Control (DEVICE).
Who is sponsoring clinical trial NCT07127913?
This trial is sponsored by Andrew Krystal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07127913 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
Similar trials for Bipolar II Disorder
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 NCT07127913's enrollment target sits among peer trials
10 14th of 14 the lowest of 14 other Bipolar II Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar II Disorder 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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