BDDS: Berlin Deep Brain Stimulation Depression Study

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT00531726
• Collaborator: University Hospital Carl Gustav Carus (Other), Ludwig-Maximilians - University of Munich (Other), Hannover Medical School (Other)
• Enrollment: 11
• Location: 1
• Arms: 2
• Duration (Months): 72
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Treatment Resistant Depression	Device: DBS of Cg25	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• 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)
• Study Start Date: Sep 1, 2007
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: B	Device: DBS of Cg25
Experimental: A	Device: DBS of Cg25

Outcome Measures

Primary Outcome Measures

1. HAMD/MARS score reduction [4 weeks]

Secondary Outcome Measures

1. neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• 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

Locations

	Site	City	State	Country	Postal Code
1	Charité - Universitaetsmedizin Berlin	Berlin		Germany	14050

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, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Malek Bajbouj, Prof. Dr., Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT00531726
• Other Study ID Numbers: BDDS
• First Posted: Sep 19, 2007
• Last Update Posted: Jan 24, 2018
• Last Verified: Jan 1, 2018

• Additional relevant MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant

Study Results

No Results Posted as of Jan 24, 2018