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NCT06096207 · ClinicalTrials.gov registry record · Phase 1
DBS for Depression
A Phase 1 study of Treatment-Resistant Depression, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06096207: Recruiting Phase 1 study of Treatment-Resistant Depression, sponsored by Northwell Health.
NCT06096207 is a Phase 1 study of Treatment-Resistant Depression that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 20 participants, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06096207, a Phase 1 study of Treatment-Resistant Depression, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: * Is deep brain stimulation effective in treating treatment resistant depression? * Does deep brain stimulation improve overall clinical well-being and functioning? Participants will be implanted with a deep brain stimulation device. They will then be monitored over a 5-year period by using multiple questionnaires to track their depression symptoms. The device will be turned off at certain time points, unbeknown to the participant, to show the efficacy of the device when it is turned on. The device will be ON for 8.5 months and OFF for 3.5 months during the first year. Researchers will compare questionnaire scores when the device is off versus on to see if the device is working in reducing depression.
Primary Outcome
The MADRS is the Montgomery-Asberg Depression Rating Scale, which at 12 months will be the primary endpoint. The investigators hypothesize is that there will be a significant effect of being stimulated (ON) versus not simulated (OFF) on MADRS scores. Also, that at 12 months 50% of the patients will be responders.
Conditions Studied
Interventions
- DEVICE Medtronic SenSight Directional DBS lead
Study Locations (1)
New York
- Zucker Hillside Hospital - Queens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-10-18 |
| Est. Completion | 2038-10-18 |
| Phase | Phase 1 |
What NCT06096207 shows while recruiting
NCT06096207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 373-participant average among 54 other Treatment-Resistant Depression trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Treatment-Resistant Depression appearing as the primary indexed condition, and to 1 intervention - of which Medtronic SenSight Directional DBS lead is the first listed.
NCT06096207 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06096207 about?
NCT06096207 is a clinical study titled "DBS for Depression". The goal of this clinical trial is to demonstrate the feasibility and safety of deep brain stimulation in treatment resistant depression. The main questions it aims to answer are: * Is deep brain stimulation effective in treating treatment resistant depression? * Does deep brain stimulation improve...
What is the current status of trial NCT06096207?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-10-18. Estimated completion is 2038-10-18.
What conditions does trial NCT06096207 study?
This clinical trial studies the following conditions: Treatment-Resistant Depression.
What interventions are being tested in trial NCT06096207?
The interventions under investigation include: Medtronic SenSight Directional DBS lead (DEVICE).
Who is sponsoring clinical trial NCT06096207?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06096207 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Treatment-Resistant Depression
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 NCT06096207's enrollment target sits among peer trials
20 41st of 54 higher than 14 of 54 other Treatment-Resistant Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Treatment-Resistant Depression 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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