Berlin Deep Brain Stimulation Depression Study
BDDS
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)
1 other identifier
interventional
11
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 18, 2007
CompletedFirst Posted
Study publicly available on registry
September 19, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedJanuary 24, 2018
January 1, 2018
5 years
September 18, 2007
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
HAMD/MARS score reduction
4 weeks
Secondary Outcomes (1)
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
4 weeks
Study Arms (2)
B
SHAM COMPARATORA
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Charite University, Berlin, Germanylead
- University Hospital Carl Gustav Caruscollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- Hannover Medical Schoolcollaborator
Study Sites (1)
Charité - Universitaetsmedizin Berlin
Berlin, 14050, Germany
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Malek Bajbouj
Charite University, Berlin, Germany
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr.
Study Record Dates
First Submitted
September 18, 2007
First Posted
September 19, 2007
Study Start
September 1, 2007
Primary Completion
September 1, 2012
Study Completion
September 1, 2013
Last Updated
January 24, 2018
Record last verified: 2018-01