Deep Brain Stimulation for Major Depressive Disorder
Public ClinicalTrials.gov record NCT00617162. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Clinical Evaluation for the Management of Patients With Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study is designed as a prospective, multi-centered, double-blind, randomized, controlled 12-month pivotal study to evaluate the safety and efficacy of the ANS Libra® Deep Brain Stimulation System for patients with major depressive disorder who have failed at least 4 treatments in the current episode. The primary outcome assessment will occur at 6 months: however, all patients will be followed for 1 year. A total of 201 patients will be randomized from up to 20 sites. Each potential patient will be pre-screened according to the inclusion/exclusion criteria. A narrative of what study participation entails, will be used to educate potential participants on study requirements. Prior to on-site baseline evaluations, the patient will sign the informed consent. Patients will then undergo 3 baseline evaluations, with each of these evaluations to occur no less than 2 weeks apart from each other. The first 2 baseline visit evaluations will be performed by separate psychiatrists in order to confirm the patient's diagnosis. All patients will be scheduled for surgery, to occur no less than two weeks and no more than 1 month after final baseline evaluation, to implant the ANS Libra® Deep Brain Stimulation system. After device implantation, patients will be randomly assigned to 1 of 2 groups in a 2:1 ratio (Active Treatment Group \& Control Group). After system implant (Week 0), the patient will return to clinic approximately 2 weeks after surgery for evaluation and treatment randomization into either Group 1 or Group 2 (Group 1 = Active Treatment Group; Group 2 = Control Group). Patient will then return to clinic for subsequent evaluations at 2 weeks, 4 weeks, 6 weeks, 8 weeks, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 1 year post system implantation.
Study identification
- NCT ID
- NCT00617162
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 125 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 21 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 29, 2008
- Primary completion
- May 31, 2014
- Completion
- May 31, 2015
- Last update posted
- Apr 7, 2024
2008 – 2015
United States locations
- U.S. sites
- 11
- U.S. states
- 10
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| Alexian Brothers Behavioral Health Hospital | Chicago | Illinois | 60169 | — |
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | — |
| University of Minnesota Medical School | Minneapolis | Minnesota | 55455 | — |
| The Zucker Hillside Hospital | Glen Oaks | New York | 11004 | — |
| Columbia University Medical Center | New York | New York | 10032 | — |
| Medical Univeristy of South Carolina (MUSC) | Charleston | South Carolina | 29425 | — |
| Vanderbilt University | Nashville | Tennessee | 37212 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Swedish Neuroscience Institute | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00617162, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2024 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00617162 live on ClinicalTrials.gov.