Status:
COMPLETED
Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients
Lead Sponsor:
Hadassah Medical Organization
Conditions:
Parkinson's Disease
Major Depressive Disorder
Eligibility:
All Genders
40-75 years
Phase:
NA
Brief Summary
The purpose of this study is: 1. To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effec...
Detailed Description
Depressive symptoms of PD patients are major predictors of their prognosis and quality of life. Therefore, successful treatment of depression is crucial in PD patients. Using deep brain stimulation as...
Eligibility Criteria
Inclusion
- Clinically definite PD treated / candidates for treatment with DBS (patients with advanced idiopathic PD who are deemed appropriate for DBS surgery).
- Patients will be included in the study irrespective of whether a diagnosis of major depression (mild to moderate but not severe MDD) is fulfilled at baseline. Patients without depression will be monitored in the study for evidence of treatment emergent depression. Patients with depression will be monitored for antidepressant effects of stimulation change.
- Age 40-75 years
- Male or female.
- Competent and willing to give written informed consent.
Exclusion
- Significant suicidal risk \[Hamilton Depression scale item 3 (suicide) \>2\].
- Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
- Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months
- Significant cognitive decline, as measured by Addenbrooke's Cognitive Examination (ACE) and the Frontal Assessment Battery (FAB).
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00885222
Start Date
May 1 2009
End Date
May 1 2010
Last Update
June 3 2010
Active Locations (1)
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1
Hadassah Medical Organization
Jerusalem, Israel, 91120