Berlin Deep Brain Stimulation Depression Study (BDDS)
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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.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Investigation of Efficacy and Safety of Deep Brain Stimulation in Patients With Treatment Resistant Major Depression in a Multicenter, Double-blind, Prospectivly-designed Delayed-onset Study (Tiefe Hirnstimulation Zur Behandlung Therapieresistenter Depressionen-eine Multizentrische, Doppelblinde, Prospektive Studie Mit Einem Delayed-onset Design)
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Ages Eligible for Study:
25 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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