Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients

NCT00885222 | Completed

• 1 other identifier: Eitan-DBS-PD-MDD-HMO-CTIL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 1.To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects.
2. 2.To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD.
3. 3.To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS.
4. 4.To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.

Conditions

Parkinson's Disease; Major Depressive Disorder

Keywords

Parkinson's disease; Major depressive disorder; Deep brain stimulation

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure of the study will be the stimulation parameters of patients who fulfill criteria for MDD at the inception of trial and manifest remission (HAM-D21 score <7) after 4 months (or less) of DBS treatment.

  18 months

Secondary Outcomes (1)

• Secondary outcome measures will be the relationship between improvement in mental status (as measured by HAM-21, BDI, CGI, HAM-A, BPRS and PDQ39) and change in PD symptoms (as measured by UPDRS).

  18 months

Study Arms (3)

1

ACTIVE COMPARATOR

PD patient that were treated with STN DBS and developed depression after the surgery (n=5).

Device: DBS parameters setting

2

ACTIVE COMPARATOR

PD patients with depression that are candidates for STN DBS (n=5).

Device: DBS parameters setting

3

ACTIVE COMPARATOR

PD patients without depression that are candidates for STN DBS (n=10).

Device: DBS parameters setting

Interventions

DBS parameters setting DEVICE

DBS parameters will be set to increase the DBS affected volume to include both the cognitive and limbic territories in addition to the dorso-lateral motor territories of the STN. This novel approach to parameter selection is directed to achieve improvement in cognitive and limbic as well as motor domains of PD. The patients will therefore be assessed for cognitive, limbic and motor state at multiple time points; there will be a baseline assessment prior to starting treatment (prior to DBS surgery and/or prior to parameters changes); thereafter assessments will follow the stimulation parameter changes; thereafter follow-up assessments at 6 - 12 months. Stimulation parameters will be changed every 2 weeks or earlier if an urgent clinical state emerges. Patients with depression will be monitored for antidepressant effects of stimulation changes. Patients without depression will be monitored for evidence of treatment emergent depression.

1; 2; 3

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Parkinson Disease; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Renana Eitan, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Zvi Israel, MD

  Hadassah Medical Organization

  STUDY CHAIR

• Hagai Bergman, MD

  Hadassah Medical Organization

  STUDY CHAIR

• Bernard Lerer, MD

  Hadassah Medical Organization

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2009
• First Posted: April 21, 2009
• Study Start: May 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 3, 2010

Record last verified: 2010-05

Locations

IL (1)