Berlin Deep Brain Stimulation Depression Study

Treatment Resistant Depression Clinical Trial

— BDDS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00531726
• Other study ID #: BDDS
• Status: Completed
• Phase: N/A
• First received: September 18, 2007
• Last updated: January 23, 2018
• Start date: September 2007
• Est. completion date: September 2013

Study information

• Verified date: January 2018
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: September 2013
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant
• Treatment Resistant Depression

Intervention

Device:
• DBS of Cg25

Locations

Country	Name	City	State
Germany	Charité - Universitaetsmedizin Berlin	Berlin

Sponsors (4)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Hannover Medical School, Ludwig-Maximilians - University of Munich, University Hospital Carl Gustav Carus

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD/MARS score reduction		4 weeks
Secondary	neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures		4 weeks

External Links

•   contact: stimulation@charite.de