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Berlin Deep Brain Stimulation Depression Study (BDDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00531726
Recruitment Status : Completed
First Posted : September 19, 2007
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Information provided by (Responsible Party):
Malek Bajbouj, Charite University, Berlin, Germany

Study Description
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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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: DBS of Cg25 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2007
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2013

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Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: B Device: DBS of Cg25
Experimental: A Device: DBS of Cg25


Outcome Measures
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Primary Outcome Measures :
  1. HAMD/MARS score reduction [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures [ Time Frame: 4 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00531726


Locations
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Germany
Charité - Universitaetsmedizin Berlin
Berlin, Germany, 14050
Sponsors and Collaborators
Charite University, Berlin, Germany
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Investigators
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Study Director: Malek Bajbouj Charite University, Berlin, Germany
More Information
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Responsible Party: Malek Bajbouj, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00531726    
Other Study ID Numbers: BDDS
First Posted: September 19, 2007    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
 Behavioral Symptoms
Mood Disorders
Mental Disorders