Affective Processing in Depression and Epilepsy

Healthy Clinical Trial

Official title:

Affective Processing in Depression and Epilepsy; An fMRI Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00855725
• Other study ID #: GCRC 0246
• Secondary ID: 08-128
• Status: Terminated
• Phase: N/A
• First received: March 3, 2009
• Last updated: July 8, 2009
• Start date: June 2008
• Est. completion date: June 2009

Study information

• Verified date: July 2009
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The goal of this study is to determine whether there are unique markers on neuroimaging that are associated with depression in epilepsy.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Epilepsy
• Healthy

Intervention

Other:
• fMRI
Subjects will undergo MRI scanning to gather data about cognetive functions.
• Hamilton Depression Rating Scale
Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.
• Beck's Depressive Inventory
Subjects will complete self assessment to evaluate their level of depression.
• 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.

Locations

Country	Name	City	State
United States	North Shore LIJ Health System	Manhasset	New York

Sponsors (1)

Lead Sponsor	Collaborator
Northwell Health

Country where clinical trial is conducted

United States,