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NCT02046330 · ClinicalTrials.gov registry record · NA
Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression
A NA study of Major Depressive Disorder and Treatment-Resistant Depression, sponsored by The University of Texas Health Science Center, Houston.
- Active
- Registry status
- NA
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02046330 is a NA study of Major Depressive Disorder and Treatment-Resistant Depression that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 16 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02046330, a NA study of Major Depressive Disorder and Treatment-Resistant Depression, is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders, and suggest that DBS at the same site may also reduce symptomatology in these TRD patients (Schaepfer, 2013). Depression affects up to 10% of the US population and of those at least 10-15% do not benefit from therapies hence why we must explore new treatments. The Percept™ PC system manufactured by Medtronic Neurological will be used in this study. Study subjects will be between the ages of 22 and 70 years of age and suffer from TRD, have failed multiple treatment regimens, including ECT, and remain symptomatic. Those identified as TRD patients will then be enrolled in a clinical pilot study investigating DBS, targeting the MFB.
Conditions Studied
Interventions
- DEVICE Deep Brain Stimulation Model 3387 Model 3389
Study Locations (1)
Texas
- UT Center of Excellence on Mood Disorders - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-12-16 |
| Est. Completion | 2027-04-01 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02046330
The ClinicalTrials.gov registry entry for NCT02046330 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation Model 3387 Model 3389 is the first listed.
NCT02046330 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT02046330 about?
NCT02046330 is a clinical study titled "Deep Brain Stimulation (DBS) Therapy for Treatment Resistant Depression". We propose a clinical study of medial forebrain bundle DBS as a treatment in 20 patients with treatment refractory depression (TRD). Data from the University of Bonn indicates that surgical lesions of the medical forebrain bundle can produce therapeutic benefits in patients with depressive disorders...
What is the current status of trial NCT02046330?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 16 participants. The study started on 2013-12-16. Estimated completion is 2027-04-01.
What conditions does trial NCT02046330 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Treatment-Resistant Depression.
What interventions are being tested in trial NCT02046330?
The interventions under investigation include: Deep Brain Stimulation Model 3387 Model 3389 (DEVICE).
Who is sponsoring clinical trial NCT02046330?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02046330 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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