European Deep Brain Stimulation (DBS) Depression Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT01331330
First received: April 4, 2011
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

To evaluate the effects of two different programming settings of deep brain stimulation (DBS) in the subgenual white matter (Brodmann Area 25 WM) as an adjunctive treatment for TR-MDD, single or recurrent episode on mood as measured by the MADRS.


Condition Intervention
Depressive Disorder, Major
Device: Deep Brain Stimulation

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: A Clinical Evaluation of Different Device Parameters for the Management of Patients With Treatment Resistant Major Depressive Disorder, Single or Recurrent Episode, With Deep Brain Stimulation

Resource links provided by NLM:


Further study details as provided by St. Jude Medical:

Primary Outcome Measures:
  • Percentage of change from mean baseline values in MADRS score [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of change from baseline value of HDRS [ Time Frame: 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group B
Low Programming
Device: Deep Brain Stimulation
Low Programming
Other Name: Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)
Experimental: Group A
Normal Programming
Device: Deep Brain Stimulation
Normal DBS Programming
Other Name: Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division)

  Eligibility

Ages Eligible for Study:   21 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women (non-pregnant) age is 21-70 years;
  • Diagnosed with non-psychotic major depressive disorder, single or recurrent episode by DSM-IV-TR criteria derived from the MINI;
  • First episode onset before age 45;
  • Current episode > 12 month duration;
  • In the current episode: Documented resistance to a minimum of 4 adequate depression treatments from at least 3 different categories;
  • In adult lifetime (>21 year of age) have experience a period of wellness as defined by DSM IV criteria;
  • MADRS score ≥22 at 2 separate baseline visits, rated by 2 separate psychiatrists;
  • GAF score <50;
  • Mini-mental state examination (MMSE) score >24;
  • No change in current antidepressant medication regimen or medication free for at least 4 weeks prior to study entry;
  • Able to give informed consent in accordance with institutional policies;

Exclusion Criteria:

  • A diagnosis of bipolar I or bipolar II disorder by DSM-IV-TR criteria, derived from the MINI;
  • Meets criteria for borderline or antisocial personality disorder in the last 12 months by DSM-IV-TR criteria, derived from the Cluster B Personality Disorders Sections 301.7 - 301.83, preferably screened via SCID-II at Baseline visit (optional);
  • In the current depressive episode, has been diagnosed with General Anxiety Disorder (GAD) - as defined by the DSM-IV-TR, and GAD is the primary diagnosis;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331330

Locations
Austria
Paracelsus Medical University
Salzburg, Austria, 5020
France
CHU Pasteur
Nice, France, 06002
Hôpital La Pitié Salpêtrière
Paris, France, 75651
Germany
University Hospital
Bonn, Germany, D-53105
Israel
Hadassah-Hebrew University Medical Center
Jerusalem, Israel, 91120
United Kingdom
National Hospital for Neurology and Neurosurgery - UCL
London, United Kingdom, WC1N 3
King's College London
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
St. Jude Medical
  More Information

No publications provided

Responsible Party: St. Jude Medical
ClinicalTrials.gov Identifier: NCT01331330     History of Changes
Other Study ID Numbers: NM-09-035-EU-DB
Study First Received: April 4, 2011
Last Updated: February 26, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by St. Jude Medical:
Depressive Disorder
Unipolar
Implantable Stimulation Electrodes

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on August 28, 2014