Berlin Deep Brain Stimulation Depression Study

Not Applicable

Completed

• Conditions: Treatment Resistant Depression
• Interventions: Device: DBS of Cg25

• Registration Number: NCT00531726
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

In this study efficacy and safety of deep brain stimulation of the cingulate cortex in 20 patients with treatment resistant major depression will be investigated. In addition, the stress axis, the cortical GABAergic system, neurotrophins and event-related potentials will be assessed.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-18
• Study First Submitted QC: 2007-09-18
• Study First Posted: 2007-09-19
• Primary Completion: 2012-09
• Study Completion: 2013-09
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-23
• Last Update Posted: 2018-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

• patient is diagnosed with a severe major depressive episode
• patient is in a chronic current MDE and/or has had a history of recurrent MDEs
• patient has not had an acceptable clinical response due to failure with at least three antidepressant treatments during the current episode.
• patient has a score > 20 on the HAMD24
• patient is stable on current psychotropic medication for at least 6 weeks
• patient is >25 and <80 years
• Global Assessment of Function (GAF) score of < 45

Exclusion Criteria

• Atypical Depression (according to DSM IV)
• Other relevant psychiatric axis I or axis II diseases
• Relevant neurological diseases
• Relevant cardiac or pulmonary diseases with enhances anaesthesiological risk (ASA Score > 3)
• Patient is currently enrolled in another investigational study not associated with the current study
• Patient has a history of, or evidence of, significant brain malformation or significant head injury
• Patient is likely to require a whole body MRI after implantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	DBS of Cg25	-
B	DBS of Cg25	-

Primary Outcome Measures

Name	Time	Method
HAMD/MARS score reduction	4 weeks

Secondary Outcome Measures

Name	Time	Method
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures	4 weeks

Trial Locations

Locations (1)

Charité - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany