Back to resultsBerlin Deep Brain Stimulation Depression Study (BDDS)
Primary Purpose
Treatment Resistant Depression
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
DBS of Cg25
Sponsored by
About this trial
This is an interventional treatment trial for Treatment Resistant Depression
Eligibility Criteria
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
Sites / Locations
- Charité - Universitaetsmedizin Berlin
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
B
A
Arm Description
Outcomes
Primary Outcome Measures
HAMD/MARS score reduction
Secondary Outcome Measures
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
Full Information
NCT ID
NCT00531726
First Posted
September 18, 2007
Last Updated
January 23, 2018
Sponsor
Charite University, Berlin, Germany
Collaborators
University Hospital Carl Gustav Carus, Ludwig-Maximilians - University of Munich, Hannover Medical School
1. Study Identification
Unique Protocol Identification Number
NCT00531726
Brief Title
Berlin Deep Brain Stimulation Depression Study
Acronym
BDDS
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
University Hospital Carl Gustav Carus, Ludwig-Maximilians - University of Munich, Hannover Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Treatment Resistant Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
B
Arm Type
Sham Comparator
Arm Title
A
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
DBS of Cg25
Primary Outcome Measure Information:
Title
HAMD/MARS score reduction
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malek Bajbouj
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Study Director
Facility Information:
Facility Name
Charité - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Berlin Deep Brain Stimulation Depression Study
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