NCT01331330

European Deep Brain Stimulation (DBS) Depression Study

A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 21 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The European Study was a prospective, multicenter, double-blind, randomized study comparing high frequency stimulation (130 Hz) to low frequency stimulation (20 Hz). Subjects underwent 2 baseline evaluations by 2 separate psychiatrists and were implanted with the Libra DBS system. Subjects were randomized to receive either high or low frequency stimulation. The primary endpoint was evaluated after 6 months of stimulation.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation	Normal DBS Programming
DEVICE	Deep Brain Stimulation	Low Programming

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-12-01
• Completion: 2015-01-01
• First posted: 2011-04-08
• Last updated: 2024-11-14
• Results posted: 2024-11-14

Locations

5 sites across 3 countries: France, Israel, United Kingdom