Trials Sponsors Conditions Drugs Pricing

Conditions

Major Depressive Disorder Parkinson's Disease

Keywords

Parkinson's diseaseMajor depressive disorderDeep 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 settingDevice

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.

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Eligibility Criteria

Age40 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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.

Sponsors & Collaborators

Hadassah Medical Organization
Otherlead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

MeSH Terms

Conditions

Parkinson DiseaseDepressive Disorder, Major

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesDepressive DisorderMood DisordersMental 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 2009

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

May 2010

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations