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Completed

NCT Number: NCT00531726

Berlin Deep Brain Stimulation Depression Study

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.

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Key information

Conditions

Treatment Resistant Depression Depressive Disorder Depressive Disorder, Treatment-Resistant Mental Disorders Mood Disorders

Age range

25 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitaetsmedizin Berlin

Berlin, 14050, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DBS of Cg25

Device

Primary outcomes

  1. HAMD/MARS score reduction

    Time frame: 4 weeks

Secondary outcomes

  1. neurotrophic factor concentration, p300, cortical excitability measures, stress axis measures

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

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

Registry information

Official study 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)

Acronym: BDDS

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Sep 19, 2007
Registry last updated
Jan 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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