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Deep Brain Stimulation for Treatment Resistant Depression

NCT00367003 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2025-05-06

Study results available
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Summary

The purpose of this study is to test the safety, efficacy and mechanism of action of subgenual cingulate (Cg25) deep brain stimulation (DBS) for major depression in patients who have not responded to prior antidepressant treatments. Participation in the study will continue for ten years or until the device receives FDA approval for depression. Forty (40) patients will be enrolled in this study.

Conditions

Interventions

DEVICE

Deep Brain Stimulation

The deep brain stimulation system (consisting of a lead, extension wire, and implanted pulse generator) will be surgically implanted to stimulate the targeted area of the brain. Stimulation will be turned off for 4 weeks following implantation, then participants will use brain stimulation for 6 months. Participants will also take part in Behavioral Activation therapy during the 6 months of active stimulation. Participants will be followed for 10 years, or until the DBS device has been FDA approved, with adjustments made to the stimulator and medications as necessary.

Sponsors & Collaborators

  • The Dana Foundation

    collaborator OTHER

  • Emory University

    lead OTHER

Principal Investigators

  • Patricio Riva Posse, MD · Emory University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2014-01-02
Completion
2029-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367003 on ClinicalTrials.gov