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NCT00367003 · ClinicalTrials.gov registry record · NA

Deep Brain Stimulation for Treatment Resistant Depression

A NA study of Major Depressive Disorder, sponsored by Emory University.

Active
Registry status
NA
Development phase
37
Enrollment target
1
Study location

NCT00367003: Active NA study of Major Depressive Disorder, sponsored by Emory University.

NCT00367003 is a NA study of Major Depressive Disorder that is active but no longer recruiting, run by Emory University. The registered enrollment target is 37 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00367003, a NA study of Major Depressive Disorder, is active but no longer recruiting, sponsored by Emory University.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
37 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

The Hamilton Depression Rating Scale (HDRS-17) contains 17 items that are scored from 0 to 2, 3, or 4, where 0 is lack of difficulty and the highest number for an item is the most extreme difficulty. Total scores range from 0 to 53 and higher scores indicate greater depression. For this study, a response to treatment will be defined as a decrease in the HDRS-17 score of 50% or greater from the average pre-surgical baseline.

Conditions Studied

Interventions

  • DEVICE Deep Brain Stimulation

Study Locations (1)

Georgia

  • Emory University School of Medicine - Atlanta

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2006-09
Est. Completion 2029-01
Phase NA
Emory University

1,208 total trials

What the registry record for NCT00367003 still lists

NCT00367003 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (90% lower).

The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 1 intervention - of which Deep Brain Stimulation is the first listed.

NCT00367003 reports a single indexed study location in Georgia.

Frequently Asked Questions

What is clinical trial NCT00367003 about?

NCT00367003 is a clinical study titled "Deep Brain Stimulation for Treatment Resistant Depression". 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...

What is the current status of trial NCT00367003?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 37 participants. The study started on 2006-09. Estimated completion is 2029-01.

What conditions does trial NCT00367003 study?

This clinical trial studies the following conditions: Major Depressive Disorder.

What interventions are being tested in trial NCT00367003?

The interventions under investigation include: Deep Brain Stimulation (DEVICE).

Who is sponsoring clinical trial NCT00367003?

This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00367003 being conducted?

This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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 NCT00367003's enrollment target sits among peer trials

37 211th of 282 higher than 71 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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Source: ClinicalTrials.gov NCT00367003, the US trial registry maintained by the National Library of Medicine. NCT00367003 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.