Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01476527
First received: November 15, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

Bipolar Disorder (BD) is among the most comon and challenging conditions in psychiatry. Although episodes of mania and hypomania define the different types of the disorder, the clinical picture is one dominated by depressed mood and agitation. The mainstay of BD treatment has thus far been pharmacologic, but many patients remain severely disabled by their condition, despite the best available medical treatment. The successful use of deep brain stimulation (DBS) in movement disorders, and its promising results in major depressive disorder (MDD), has led researchers to consider its use in highly selected refractory cases of BD. Evidence form the imaging and circuitry literature suggests that similar underlying dyfunctional anatomic structures subserve both MDD and BD, indicating that modulation of key structures, can lead to an amelioration of symptoms and mood stabilization. Here, we propose a phase I clinical trial to evaluate the safety of DBS in BD.


Condition Intervention Phase
Bipolar Disorder
Procedure: Deep Brain Stimulation
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Depression [ Time Frame: Change from baseline in depression scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS)


Secondary Outcome Measures:
  • Young Mania Rating Scale [ Time Frame: Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
  • Quality of Life [ Time Frame: Change from baseline in quality of life scores at 3 months, 6 months and 12 months ] [ Designated as safety issue: No ]
    Short Form Health Survey (SF36)


Estimated Enrollment: 6
Study Start Date: May 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Deep Brain Stimulation
    Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone
  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or Female patients between the age of 30-60
  • DSM IV-TR diagnosis of Bipolar Disorder I or II
  • Diagnosis for >12 months with a HRSD-17 score of at least 20
  • Failure of medical therapy, defined as follows:

    a. Failure of a minimum of two (2) first line as well as two (2) second line treatments for bipolar mania and depression

  • No neurological disease
  • No other active Axis I or Axis II co-morbidity that is the focus of clinical attention, as defined by the Mini International Neuropsychiatric Interview (MINI)
  • No substance abuse or substance use disorder for minimum of three months prior to study
  • Able to give informed consent
  • Able to comply with all testing and follow-up visit requirements defined by the Study Protocol
  • Mini mental status examination (MMSE) score >25
  • Pre-menopausal women must agree to use acceptable methods of birth control (radiation risk of PET)

Exclusion Criteria:

  • History of psychosis, or psychotic episodes
  • Alcohol or substance dependence or abuse within 6 months, excluding nicotine or caffeine.
  • Current suicidal ideation, plan or intent for self-harm.
  • A suicide attempt in the past 1 year
  • Major medical illness, cardiac pacemaker/defibrillator, and other implanted stimulator
  • Likely to relocate or move to a location distant from the study site within one year of enrollment
  • Any contraindication to MRI or PET scanning
  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: NCT01476527

Contacts
Contact: Nir Lipsman, MD 416-790-1780 nir.lipsman@utoronto.ca

Locations
Canada, Ontario
Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Andres M Lozano, MD PhD University Health Network, Toronto
Principal Investigator: Roger McIntyre, MD University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Andres M. Lozano, Neurosurgeon, Professor of Surgery, University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01476527     History of Changes
Other Study ID Numbers: 10-0696-A
Study First Received: November 15, 2011
Last Updated: November 17, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014