Status:
COMPLETED
Deep Brain Stimulation for the Treatment of Refractory Bipolar Disorder
Lead Sponsor:
University Health Network, Toronto
Conditions:
Bipolar Disorder
Eligibility:
All Genders
30-60 years
Phase:
NA
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...
Detailed Description
Bipolar disorder (BD) is a complex and disabling disorder that is among the most challenging diagnoses in psychiatry. Although episodes of mania and hypomania define the different types of the disorde...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01476527
Start Date
May 1 2011
End Date
June 1 2014
Last Update
October 30 2019
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8