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Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2011 by Andres M. Lozano, University Health Network, Toronto.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andres M. Lozano, University Health Network, Toronto
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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Andres M. Lozano, University Health Network, Toronto:

Primary Outcome Measures:
  • 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:
  • Young Mania Rating Scale [ Time Frame: Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months ]
  • 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)

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

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

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
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

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

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

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 Submitted: November 15, 2011
First Posted: November 22, 2011
Last Update Posted: November 22, 2011
Last Verified: November 2011

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