Parkinson's DiseaseNCT00885222
Antidepressant Effect of Deep Brain Stimulation in Parkinson's Disease Patients
A study testing DBS parameters setting in people with Parkinson's Disease and Major Depressive Disorder, run by Hadassah Medical Organization at 1 site in Israel.
Trial 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 effects. 2. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson's Disease, Major Depressive Disorder
- What is being tested?
- DBS parameters setting
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- May 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antidepressant Effect of Deep Brain Stimulation (DBS) in Parkinson's Disease (PD) Patients: Relationship of Stimulation Parameters to Improvement in the Clinical Features of Depression in PD Patients.
The purpose of this study is:
- To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects.
- To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD.
- To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS.
- To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.
Read the 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 an antidepressant (or to augment a standard antidepressant) could be a promising new direction. The hypothesis to be tested in the current project is that treatment with deep brain stimulation will improve both the neurological and the psychiatric (depressive) symptoms of PD. It is further hypothesized that the improvement in depressive symptoms will not be a simple consequence of improvement in neurological status. Data from this open label study will form the basis for planning a larger scale controlled trial in depressed PD patients and exploratory studies in patients with major depression who do not have PD.
Today, programming of DBS is based on the neurological evaluation of the motor features of PD. If our hypothesis is proven, i.e. parameter manipulation of DBS affects the mental features of PD, it is crucial to establish a valid database that will enable to study these effects. Moreover, such a detailed database will be the basis for the development of a computer-assisted decision making protocol for programming of DBS. A novel decision making protocol will maximize the benefits of DBS in both depressed and non-depressed PD patients.
- Conditions
- Parkinson's Disease, Major Depressive Disorder
- Being tested
- DBS parameters setting
- Keywords
- Parkinson's disease, Major depressive disorder, Deep brain stimulation
- Medical subject headings
- Parkinson Disease, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | PD patient that were treated with STN DBS and developed depression after the surgery (n=5). Receives: Device: DBS parameters setting |
| 2 | Active comparator | PD patients with depression that are candidates for STN DBS (n=5). Receives: Device: DBS parameters setting |
| 3 | Active comparator | PD patients without depression that are candidates for STN DBS (n=10). Receives: Device: DBS parameters setting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Renana Eitan, MD, Principal investigator, Hadassah Medical OrganizationZvi Israel, MD, Study chair, Hadassah Medical OrganizationHagai Bergman, MD, Study chair, Hadassah Medical OrganizationBernard Lerer, MD, Study chair, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885222
- Sponsor's protocol ID
- Eitan-DBS-PD-MDD-HMO-CTIL
- Status last verified
- May 2010
- First submitted
- 20 Apr 2009
- Last updated
- 3 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antidepressant Effect of Deep Brain Stimulation (DBS) in Parkinson's Disease (PD) Patients: Relationship of Stimulation Parameters to Improvement in the Clinical Features of Depression in PD Patients.
- ClinicalTrials.gov ID
- NCT00885222
- Acronym / sponsor ID
- Eitan-DBS-PD-MDD-HMO-CTIL
- Conditions
- Parkinson's Disease, Major Depressive Disorder
- Keywords
- Parkinson's disease, Major depressive disorder, Deep brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is:
- To determine, in the context of a prospective clinical trial, whether stimulation parameters in PD patients treated with DBS, are associated with antidepressant effects.
- To determine whether these antidepressant effects are related to or independent of changes in the motor features of PD.
- To establish a computerized database that includes stimulation parameters and clinical parameters in PD patients treated with DBS.
- To develop a computer-assisted decision making protocol for programming of DBS parameters in both depressed and non-depressed PD patients.
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 an antidepressant (or to augment a standard antidepressant) could be a promising new direction. The hypothesis to be tested in the current project is that treatment with deep brain stimulation will improve both the neurological and the psychiatric (depressive) symptoms of PD. It is further hypothesized that the improvement in depressive symptoms will not be a simple consequence of improvement in neurological status. Data from this open label study will form the basis for planning a larger scale controlled trial in depressed PD patients and exploratory studies in patients with major depression who do not have PD.
Today, programming of DBS is based on the neurological evaluation of the motor features of PD. If our hypothesis is proven, i.e. parameter manipulation of DBS affects the mental features of PD, it is crucial to establish a valid database that will enable to study these effects. Moreover, such a detailed database will be the basis for the development of a computer-assisted decision making protocol for programming of DBS. A novel decision making protocol will maximize the benefits of DBS in both depressed and non-depressed PD patients.
Study design
- Primary purpose
- Treatment
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Device: DBS parameters settingPD patient that were treated with STN DBS and developed depression after the surgery (n=5). |
| 2 | Active comparator | Device: DBS parameters settingPD patients with depression that are candidates for STN DBS (n=5). |
| 3 | Active comparator | Device: DBS parameters settingPD patients without depression that are candidates for STN DBS (n=10). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS parameters settingDBS 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. | Device | 1, 2, 3 |
Primary outcome
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.
Time frame: 18 months
1 secondary outcome
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).
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renana Eitan, MD principal investigator
Hadassah Medical Organization
Zvi Israel, MD study chair
Hadassah Medical Organization
Hagai Bergman, MD study chair
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBS parameters setting in people with Parkinson's Disease and Major Depressive Disorder, run by Hadassah Medical Organization at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2010.