European Deep Brain Stimulation (DBS) Depression Study

May 18, 2015 updated by: Abbott Medical Devices

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

9

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06002
        • Chu Pasteur
      • Paris, France, 75651
        • Hôpital La Pitié Salpêtrière
  • Israel
      • Jerusalem, Israel, 91120
        • Hadassah-Hebrew University Medical Center
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College London
      • London, United Kingdom, WC1N 3
        • National Hospital for Neurology and Neurosurgery - UCL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Group B
Low Programming
Device: Deep Brain Stimulation
Normal DBS Programming
Other Names:
  • Libra Deep Brain Stimulation System (St. Jude Medical Neuromodulation Division)
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)
Device: Deep Brain Stimulation
Low Programming
Other Names:
  • Libra Deep Brain Stimulation System(St. Jude Medical Neuromodulation Division)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of change from mean baseline values in MADRS score
Time Frame: 6 Months
6 Months

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of change from baseline value of HDRS
Time Frame: 3, 6, 9, and 12 months
3, 6, 9, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Study Director: DeLea Peichel, Abbott Medical Devices

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

January 1, 2015

Study Registration Dates

First Submitted

April 4, 2011

First Submitted That Met QC Criteria

April 6, 2011

First Posted (ESTIMATE)

April 8, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 18, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NM-09-035-EU-DB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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