- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00855725
Affective Processing in Depression and Epilepsy
July 8, 2009 updated by: Northwell Health
Affective Processing in Depression and Epilepsy; An fMRI Study
The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Study Overview
Status
Terminated
Conditions
Detailed Description
Symptoms of depression is commonly seen in patients with epilepsy.
There are similarities and differences between depressive symptoms in epilepsy when compared with primary depression.
Through the use of fMRI (Functional MRI), we hope to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.
Study Type
Observational
Enrollment (Actual)
14
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Manhasset, New York, United States, 11030
- North Shore Lij Health System
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
There are four study groups.
- Healthy Controls
- Subjects with epilepsy only
- Subjects with primary depression only
- Subjects with epilepsy and depressive symptoms.
Description
For Control Group
Inclusion Criteria:
- Healthy adults of 18 years of age or older.
Exclusion Criteria:
- Subject has no history of affective disorders
- Subject scores higher than 5 on Hamilton Depression Rating Scale
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Epilepsy Only Group
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject has confirmed temporal lobe epilepsy (TLE)
Exclusion Criteria:
- Subject has a history of depression
- Subject scores higher then 5 on Hamilton Depression Rating Scale
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Depression Only Group
Inclusion Criteria:
- Subject is at least 18 years of age
- Subject scores between 12 and 18 on Hamilton Depression Rating Scale
Exclusion Criteria:
- Subject scores higher than 18 on Hamilton Depression Rating Scale
- Subject is currently being medicated for depression
- Subject has history of major depression or dysthymia
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Depression and Epilepsy Group
Inclusion Criteria:
- Subject has confirmed temporal lobe epilepsy (TLE)
- Subject scores between 12 and 18 on Hamilton Depression Rating Scale
Exclusion Criteria:
- Subject has history of major depression or dysthymia
- Subject is currently on medication for depression
- Subject with prior primary diagnosis of any psychotic disorder, bipolar disorder, anxiety disorder, or any other serious medical or neurological disorder
- Subject is pregnant
- Subject is unable to undergo a MRI
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Alan Ettinger, M.D., Northwell Health
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
March 3, 2009
First Submitted That Met QC Criteria
March 3, 2009
First Posted (Estimate)
March 4, 2009
Study Record Updates
Last Update Posted (Estimate)
July 9, 2009
Last Update Submitted That Met QC Criteria
July 8, 2009
Last Verified
July 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCRC 0246
- 08-128
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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