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Berlin Deep Brain Stimulation Depression Study (BDDS)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2007 by Charite University, Berlin, Germany.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: September 19, 2007
Last Update Posted: July 14, 2011
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.
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Information provided by:
Charite University, Berlin, Germany
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 Intervention Phase
Treatment Resistant Depression Device: DBS of Cg25 Phase 3

Study Type: Interventional
Study Design: 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)

Further study details as provided by Charite University, Berlin, Germany:

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

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

Estimated Enrollment: 20
Study Start Date: September 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: B Device: DBS of Cg25
Experimental: A Device: DBS of Cg25


Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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

Contact: Lara Rzesnitzek, MD +49 30 8445 8780 lara.rzesnitzek@charite.de
Contact: Bettina Wächter, MD bettina.waechter@charite.de

Charité - Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 14050
Contact: Malek Bajbouj    +49 30 8445 8623    malek.bajbouj@charite.de   
Contact: Malek Bajbouj    +49 30 8445 8622    malek.bajbouj@charite.de   
Principal Investigator: Malek Bajbouj, MD, PhD         
Sponsors and Collaborators
Charite University, Berlin, Germany
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Study Director: Malek Bajbouj Charite University, Berlin, Germany
  More Information

Responsible Party: Malek Bajbouj/MD, Klinik für Psychiatrie und Psychotherapie, Charité Universitätsmedizin, Berlin, Germany
ClinicalTrials.gov Identifier: NCT00531726     History of Changes
Other Study ID Numbers: BDDS
First Submitted: September 18, 2007
First Posted: September 19, 2007
Last Update Posted: July 14, 2011
Last Verified: September 2007

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders