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Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder

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ClinicalTrials.gov Identifier: NCT01476527
Recruitment Status : Unknown
Verified November 2011 by Andres M. Lozano, University Health Network, Toronto.
Recruitment status was:  Recruiting
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Bipolar Disorder Procedure: Deep Brain Stimulation Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2011
Estimated Primary Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder
U.S. FDA Resources


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


Primary Outcome Measures :
  1. Depression [ Time Frame: Change from baseline in depression scores at 3 months, 6 months and 12 months ]
    Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS)


Secondary Outcome Measures :
  1. Young Mania Rating Scale [ Time Frame: Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months ]
  2. Quality of Life [ Time Frame: Change from baseline in quality of life scores at 3 months, 6 months and 12 months ]
    Short Form Health Survey (SF36)



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders