Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2007-09-30
2013-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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B
DBS of Cg25
A
DBS of Cg25
Interventions
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DBS of Cg25
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
25 Years
80 Years
ALL
No
Sponsors
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University Hospital Carl Gustav Carus
OTHER
Ludwig-Maximilians - University of Munich
OTHER
Hannover Medical School
OTHER
Charite University, Berlin, Germany
OTHER
Responsible Party
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Malek Bajbouj
Prof. Dr.
Principal Investigators
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Malek Bajbouj
Role: STUDY_DIRECTOR
Charite University, Berlin, Germany
Locations
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Charité - Universitaetsmedizin Berlin
Berlin, , Germany
Countries
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Other Identifiers
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BDDS
Identifier Type: -
Identifier Source: org_study_id
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