Berlin Deep Brain Stimulation Depression Study (BDDS)

This study is currently recruiting participants.

Verified September 2007 by Charite University, Berlin, Germany

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

History of Changes

Tracking Information

First Received Date ^ICMJE

September 18, 2007

Last Updated Date

July 13, 2011

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

HAMD/MARS score reduction [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

HAMD/MARS score reduction [ Time Frame: 4 weeks ]

Change History

Complete list of historical versions of study NCT00531726 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures [ Time Frame: 4 weeks ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Berlin Deep Brain Stimulation Depression Study

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Treatment Resistant Depression

Intervention ^ICMJE

Device: DBS of Cg25

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

September 2013

Estimated Primary Completion Date

September 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00531726

Other Study ID Numbers ^ICMJE

BDDS

Has Data Monitoring Committee

Yes

Responsible Party

Malek Bajbouj/MD, Klinik für Psychiatrie und Psychotherapie, Charité Universitätsmedizin, Berlin, Germany

Study Sponsor ^ICMJE

Charite University, Berlin, Germany

Collaborators ^ICMJE

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

Investigators ^ICMJE

Study Director:

Malek Bajbouj

Charité Berlin

Information Provided By

Charite University, Berlin, Germany

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top