Berlin Deep Brain Stimulation Depression Study

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)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00531726

Acronym

BDDS

Enrollment

Registered

2007-09-19

Start date

2007-09-30

Completion date

2013-09-30

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Treatment Resistant Depression

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.

Interventions

DEVICEDBS of Cg25

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

25 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
HAMD/MARS score reduction	4 weeks

Secondary

Measure	Time frame
neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures	4 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026