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Electrical Stimulation of the Internal Capsule for Intractable Depression

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Dr. Benjamin Greenberg, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01069952
First received: February 16, 2010
Last updated: July 23, 2012
Last verified: July 2012
  Purpose

This study will evaluate the safety and efficacy of deep brain stimulation in treating people with several and otherwise treatment-resistant depression.


Condition Intervention Phase
Depression
Device: Deep Brain Stimulation System
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Electrical Stimulation of the Internal Capsule for Intractable Depression

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Hamilton Depression Rating Scale (HDRS) [ Time Frame: Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inventory for Depressive Symptoms, Self Report (IDS-SR) [ Time Frame: Administered at base line, every 1 to 5 days during the acute phase (2 months), monthly during the chronic phase, then every three months during the open continuation phase ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: December 2002
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active DBS
Participants will receive deep brain stimulation.
Device: Deep Brain Stimulation System
In DBS, thin wires are used to carry electric current to the parts of the brain involved in depression symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
Other Names:
  • Deep Brain Stimulation System from Medtronic, Inc.
  • Implantable Neurostimulator (INS)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Major depression, severe, unipolar type, diagnosed by Structural Clinical Interview for DSM-IV (SCID-IV), judged to be of disabling severity.
  • 24-item Hamilton Depression Rating Scale (HDRS) of at least 21.
  • Global Assessment of Function (GAF) score of 45 or less.
  • A recurrent (greater than or equal to 4 episodes) or chronic (episode duration greater than or equal to two years) course and a minimum of 5 years since the onset of the first depressive episode. Major impairment in functioning or potentially severe medical outcomes (repeated hospitalizations, serious suicidal or other self-injurious behavior).
  • Failure to respond to respond to:

    1. Adequate trials (greater than or equal to 6 weeks at the maximum recommended or tolerated dose) of primary antidepressants from at least 3 different classes and;
    2. Adequate trials (greater than or equal to 4 weeks at the usually recommended or maximum tolerated dose of augmentation/combination of a primary antidepressant using at least 2 different augmenting/combination agents (lithium, T3, stimulants, neuroleptics, anticonvulsants, buspirone, or a second primary antidepressant) and;
    3. An adequate trial of individual psychotherapy (greater than or equal to 20 sessions with an experienced psychotherapist)
  • Age 18 to 65 years
  • Able to comply with the operational and administrative requirements of participation in the study.
  • Able to give written informed consent.
  • Either drug-free or on a stable drug regimen for at least 6 weeks at the time of entry into the study.
  • Good general health.

Exclusion Criteria:

  • Current or past non-affective psychotic disorder.
  • Any current clinically significant neurological disorder or medical illness affecting brain function, other than motor tics or Gilles de la Tourette syndrome.
  • Any clinically significant abnormality on preoperative magnetic resonance imaging (MRI).
  • Any surgical contraindications to undergoing DBS, including labeled contraindications for DBS and/or inability to undergo pre-surgical MRI (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), infection coagulopathy, inability to undergo an awake operation, significant cardiac or other medical risk factors for surgery.
  • Current or unstably remitted substance abuse.
  • Pregnancy and women of childbearing age not using effective contraception.
  • History of severe personality disorder.
  • Imminent risk of suicide (based on the judgment of the investigators).
  • Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators).
  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: NCT01069952

Locations
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
Butler Hospital
Medtronic
Investigators
Principal Investigator: Benjamin D Greenberg, MD, PhD Butler Hospital/Brown University
  More Information

Publications:
Responsible Party: Dr. Benjamin Greenberg, Chief of Outpatient Services, Associate Professor of Psychiatry, Butler Hospital
ClinicalTrials.gov Identifier: NCT01069952     History of Changes
Other Study ID Numbers: G010351, 0201-001
Study First Received: February 16, 2010
Last Updated: July 23, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Butler Hospital:
Deep Brain Stimulation
Treatment Refractory
Neurosurgery
Implantable Neurostimulator (INS)
Internal Capsule

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

ClinicalTrials.gov processed this record on November 23, 2014