Berlin Deep Brain Stimulation Depression Study

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