European Deep Brain Stimulation (DBS) Depression Study

NCT01331330 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-11-14

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Summary

To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for treatment resistant Major Depressive Disorder (TR-MDD), single or recurrent episode on mood as measured by the MADRS.

Conditions

  • Depressive Disorder, Major

Interventions

DEVICE

Deep Brain Stimulation

Normal DBS Programming

DEVICE

Deep Brain Stimulation

Low Programming

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Nicole Harbert · Abbott Medical Devices

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • France
  • Israel
  • United Kingdom

Study Locations

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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 NCT01331330 on ClinicalTrials.gov