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Affective Processing in Depression and Epilepsy

This study has been terminated.
(PI wanted to discontinue study.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00855725
First Posted: March 4, 2009
Last Update Posted: July 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Northwell Health
  Purpose
The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.

Condition Intervention
Epilepsy Depression Healthy Other: fMRI Other: Hamilton Depression Rating Scale Other: Beck's Depressive Inventory Other: Interictal Dysphoric Disorder Inventory (IDDI)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Affective Processing in Depression and Epilepsy; An fMRI Study

Resource links provided by NLM:


Further study details as provided by Northwell Health:

Enrollment: 14
Study Start Date: June 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: fMRI
    Subjects will undergo MRI scanning to gather data about cognetive functions.
    Other: Hamilton Depression Rating Scale
    Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.
    Other: Beck's Depressive Inventory
    Subjects will complete self assessment to evaluate their level of depression.
    Other: Interictal Dysphoric Disorder Inventory (IDDI)
    Subject will complete self assessment to determine if there have been any changes in mood, emotions and or feelings from time to time.
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

There are four study groups.

  1. Healthy Controls
  2. Subjects with epilepsy only
  3. Subjects with primary depression only
  4. Subjects with epilepsy and depressive symptoms.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00855725


Locations
United States, New York
North Shore LIJ Health System
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
Principal Investigator: Alan Ettinger, M.D. Northwell Health
  More Information

Responsible Party: Alan Ettinger, M.D., Vice Chairman, Department of Neurology
ClinicalTrials.gov Identifier: NCT00855725     History of Changes
Other Study ID Numbers: GCRC 0246
08-128
First Submitted: March 3, 2009
First Posted: March 4, 2009
Last Update Posted: July 9, 2009
Last Verified: July 2009

Keywords provided by Northwell Health:
Epilepsy
Depression
Neurology
fMRI
Healthy Controls

Additional relevant MeSH terms:
Depression
Depressive Disorder
Epilepsy
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases