Berlin Deep Brain Stimulation Depression Study (BDDS)
This study is currently recruiting participants.
Verified September 2007 by Charite University, Berlin, Germany
Sponsor:
Charite University, Berlin, Germany
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
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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 June 18, 2013