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NCT04004169 · ClinicalTrials.gov registry record · NA
Closed-Loop Deep Brain Stimulation for Major Depression
A NA study of Major Depressive Disorder, sponsored by Andrew Krystal.
- Recruiting
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04004169: Recruiting NA study of Major Depressive Disorder, sponsored by Andrew Krystal.
NCT04004169 is a NA study of Major Depressive Disorder that is actively recruiting participants, run by Andrew Krystal. The registered enrollment target is 12 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04004169, a NA study of Major Depressive Disorder, is actively recruiting participants, sponsored by Andrew Krystal.
- RECRUITING
- Registry status
- NA
- Development phase
- 12 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 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 depression.
Primary Outcome
Effect size of active compared to sham stimulation (mean difference in Montgomery Asberg Depression Rating Scale (MADRS) score before and after the sham and treatment periods). Higher MADRS score indicates more severe depression; the overall score ranges from 0 to 60.
Conditions Studied
Interventions
- DEVICE Stimulation-ON
- DEVICE Stimulation-OFF
- DEVICE Stimulation-ON Active Control
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2019-07-18 |
| Est. Completion | 2035-06-28 |
| Phase | NA |
What NCT04004169 shows while recruiting
NCT04004169 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 3 interventions - of which Stimulation-ON is the first listed.
NCT04004169 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04004169 about?
NCT04004169 is a clinical study titled "Closed-Loop Deep Brain Stimulation for Major 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 NCT04004169?
This trial is currently recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2019-07-18. Estimated completion is 2035-06-28.
What conditions does trial NCT04004169 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT04004169?
The interventions under investigation include: Stimulation-ON (DEVICE), Stimulation-OFF (DEVICE), Stimulation-ON Active Control (DEVICE).
Who is sponsoring clinical trial NCT04004169?
This trial is sponsored by Andrew Krystal, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04004169 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 Major Depressive 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 NCT04004169's enrollment target sits among peer trials
12 265th of 282 higher than 15 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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