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Berlin Deep Brain Stimulation Depression Study | Clinical Trials | Clareo Health

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COMPLETEDNANCT00531726

Berlin Deep Brain Stimulation Depression Study

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 cor...

Lead sponsor: Charite University, Berlin, Germany•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Charite University, Berlin, Germany

Collaborators

University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School

Age

25 - 80 years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: January 24, 2018Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment11

Start dateSep 2007

Last updatedJan 24, 2018

Condition

Treatment Resistant Depression

Locations shown

Charité - Universitaetsmedizin Berlin

Berlin

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 24, 2018Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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