Affective Processing in Depression and Epilepsy - Full Text View

Sponsored by:	North Shore Long Island Jewish Health System
Information provided by:	North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT00855725

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)

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Depression Epilepsy

U.S. FDA Resources

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

Further study details as provided by North Shore Long Island Jewish Health System:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	80
Study Start Date:	June 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Subjects will undergo MRI scanning to gather data about cognetive functions.

Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.

Subjects will complete self assessment to evaluate their level of depression.

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00855725

Contacts

Contact: Steven Sheng, B.A. M.S.

516-562-3642

ssheng@nshs.edu

Locations

United States, New York
North Shore LIJ Health System	Recruiting
Manhasset, New York, United States, 11030
Sub-Investigator: Gad Klein, Ph.D.
Sub-Investigator: Peter Kingsley, Ph.D.
Sub-Investigator: Kenneth Perrine, Ph.D.
Sub-Investigator: Radhika Adiga, M.D.

Sponsors and Collaborators

North Shore Long Island Jewish Health System

Investigators

Principal Investigator:

Alan Ettinger, M.D.

North Shore LIJ Health System

More Information

No publications provided

Responsible Party:	Vice Chairman, Department of Neurology ( Alan Ettinger, M.D. )
Study ID Numbers:	GCRC 0246
Study First Received:	March 3, 2009
Last Updated:	March 3, 2009
ClinicalTrials.gov Identifier:	NCT00855725 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:

Epilepsy
Depression
Neurology
fMRI
Healthy Controls

Study placed in the following topic categories:

Depression
Mental Disorders
Epilepsy
Mood Disorders
Central Nervous System Diseases

Healthy
Brain Diseases
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Epilepsy
Nervous System Diseases
Mood Disorders

Central Nervous System Diseases
Brain Diseases
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 06, 2009