Berlin Deep Brain Stimulation Depression Study (BDDS)

• ClinicalTrials.gov Identifier: NCT00531726
• Recruitment Status: Completed
• First Posted: September 19, 2007
• Last Update Posted: January 24, 2018
• Sponsor: Charite University, Berlin, Germany
• 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

Tracking Information

• First Submitted Date: September 18, 2007
• First Posted Date: September 19, 2007
• Last Update Posted Date: January 24, 2018
• Study Start Date: September 2007
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 18, 2007): HAMD/MARS score reduction [ Time Frame: 4 weeks ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: September 18, 2007): neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures [ Time Frame: 4 weeks ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Berlin Deep Brain Stimulation Depression Study
• 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)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Treatment Resistant Depression
• Intervention: Device: DBS of Cg25

Study Arms

• Sham Comparator: B
  Intervention: Device: DBS of Cg25
• Experimental: A
  Intervention: Device: DBS of Cg25

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 23, 2018): 11
• Original Enrollment: Not Provided
• Actual Study Completion Date: September 2013
• Actual Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 25 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT00531726
• Other Study ID Numbers: BDDS
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Malek Bajbouj, Charite University, Berlin, Germany
• Original Responsible Party: Not Provided
• Current Study Sponsor: Charite University, Berlin, Germany
• Original Study Sponsor: Same as current

Collaborators

• University Hospital Carl Gustav Carus
• Ludwig-Maximilians - University of Munich
• Hannover Medical School

Investigators

• Study Director: Malek Bajbouj; Charite University, Berlin, Germany

• PRS Account: Charite University, Berlin, Germany
• Verification Date: January 2018