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
Sponsor:
Collaborators:
University Hospital Carl Gustav Carus
Ludwig-Maximilians - University of Munich
Hannover Medical School
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00531726
First received: September 18, 2007
Last updated: July 13, 2011
Last verified: September 2007
  Purpose

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)

Resource links provided by NLM:


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

  Eligibility

Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00531726

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

Locations
Germany
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
Investigators
Study Director: Malek Bajbouj Charité Berlin
  More Information

Additional Information:
No publications provided

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
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:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014