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European Deep Brain Stimulation (DBS) Depression Study

Sponsor
Abbott Medical Devices (Industry)
Overall Status
Completed
CT.gov ID
NCT01331330
Collaborator
(none)
9
Enrollment
5
Locations
2
Arms
44.1
Duration (Months)
1.8
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: Deep Brain Stimulation
  • Device: Deep Brain Stimulation
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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
Study Start Date :
May 1, 2011
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Jan 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Group B

Low Programming

Device: Deep Brain Stimulation
Low Programming
Other Names:
  • Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)

    		•
    Experimental: Group A

    Normal Programming

    Device: Deep Brain Stimulation
    Normal DBS Programming
    Other Names:
  • Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of change from mean baseline values in MADRS score [6 Months]

    Secondary Outcome Measures

    1. Percentage of change from baseline value of HDRS [3, 6, 9, and 12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 CHU Pasteur Nice France 06002
    2 Hôpital La Pitié Salpêtrière Paris France 75651
    3 Hadassah-Hebrew University Medical Center Jerusalem Israel 91120
    4 King's College London London United Kingdom SE5 9RS
    5 National Hospital for Neurology and Neurosurgery - UCL London United Kingdom WC1N 3

    Sponsors and Collaborators

    • Abbott Medical Devices

    Investigators

    • Study Director: DeLea Peichel, Abbott Medical Devices

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Abbott Medical Devices
    ClinicalTrials.gov Identifier:
    NCT01331330
    Other Study ID Numbers:
    • NM-09-035-EU-DB
    First Posted:
    Apr 8, 2011
    Last Update Posted:
    May 19, 2015
    Last Verified:
    May 1, 2015
    Keywords provided by Abbott Medical Devices
    Depressive Disorder
    Unipolar
    Implantable Stimulation Electrodes
    Additional relevant MeSH terms:
    Depressive Disorder
    Depression
    Depressive Disorder, Major

    Study Results

    No Results Posted as of May 19, 2015