NCT01268137

DBS in Treatment Resistant Major Depression

DEEP BRAIN STIMULATION IN TREATMENT RESISTANT MAJOR DEPRESSION. Controlled and Crossed Study on Efficacy and Safety.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims at assessing efficacy and safety of DBS for treatment of patients suffering from resistant major depression, by means of a random, controlled and crossed study.

Detailed description

The first phase of the study will consist of implanting electrodes and applying continuous stimulation until the patients stabilise clinically. This period is anticipated between 6 and 9 months. The next phase will consist of the crossover study. Responders will be randomised to either of 2 groups for a period of 3 months: a stimulation-on group and a stimulation-off group. Patients will then be crossed over to the other group for a further 3 months. Fortnightly visits will be made during the entire study to evaluate treatment efficacy and patient tolerance

Conditions

• Resistant Major Depressive Disorder

Interventions

Type	Name	Description
PROCEDURE	Deep Brain Stimulation	Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device

Timeline

• Start date: 2008-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-12-29
• Last updated: 2010-12-29

Locations

1 site across 1 country: Spain