Bipolar Disorder Clinical Trial
Official title:
Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder: Pilot Trial
NCT number | NCT01476527 |
Other study ID # | 10-0696-A |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2011 |
Est. completion date | June 2014 |
Verified date | October 2019 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 6 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 60 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Toronto Western Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hamilton Rating Scale for Depression | Hamilton Depression Rating Scale (HAMD), Montgomery-Åsberg Depression Rating Scale (MADRS) | Change from baseline in depression scores at 3 months, 6 months and 12 months | |
Secondary | Young Mania Rating Scale | Significant improvement in Young Mania Rating Scale (YMRS) | Change from baseline in manic, hypomanic scores at 3 months, 6 months and 12 months | |
Secondary | Questionnaires-Quality of Life | Short Form Health Survey (SF36) | Change from baseline in quality of life scores at 3 months, 6 months and 12 months |
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