Berlin Deep Brain Stimulation Depression Study (BDDS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2007 by Charite University, Berlin, Germany.
Recruitment status was  Recruiting
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Information provided by:
Charite University, Berlin, Germany Identifier:
First received: September 18, 2007
Last updated: July 13, 2011
Last verified: September 2007
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]

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

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


Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00531726

Contact: Lara Rzesnitzek, MD +49 30 8445 8780
Contact: Bettina Wächter, MD

Charité - Universitaetsmedizin Berlin Recruiting
Berlin, Germany, 14050
Contact: Malek Bajbouj    +49 30 8445 8623   
Contact: Malek Bajbouj    +49 30 8445 8622   
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

Additional Information:
No publications provided

Responsible Party: Malek Bajbouj/MD, Klinik für Psychiatrie und Psychotherapie, Charité Universitätsmedizin, Berlin, Germany Identifier: NCT00531726     History of Changes
Other Study ID Numbers: BDDS
Study First Received: September 18, 2007
Last Updated: July 13, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders processed this record on November 27, 2015