Affective Processing in Depression and Epilepsy | NCT00855725

Studies
Affective Processing in Depression and Epilepsy

NCT00855725

Sponsor

Northwell Health

Status

Terminated

Last Update Posted

Jul 9, 2009Estimated

Enrollment

14Actual

Phase

Not provided

Conditions

Epilepsy
Depression
Healthy

Interventions

fMRI
Hamilton Depression Rating Scale
Beck's Depressive Inventory
Interictal Dysphoric Disorder Inventory (IDDI)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
08-128

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

PI wanted to discontinue study.

Expanded Access Info

Start Date

Jun 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Actual

First Submitted Date

Mar 3, 2009

First Submission Date that Met QC Criteria

Mar 3, 2009

First Posted Date

Mar 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2009

Last Update Posted Date

Jul 9, 2009Estimated

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
fMRI	Other	Subjects will undergo MRI scanning to gather data about cognetive functions.
Hamilton Depression Rating Scale	Other	Investigator will evalute the subject during a one on one interview for depression using the Hamilton Depression Rating Scale.
Beck's Depressive Inventory	Other	Subjects will complete self assessment to evaluate their level of depression.
Interictal Dysphoric Disorder Inventory (IDDI)	Other	Subject will complete self assessment to determine if there have been any changes in mood, emotions and or feelings from time to time.

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

There are four study groups.

Healthy Controls
Subjects with epilepsy only
Subjects with primary depression only
Subjects with epilepsy and depressive symptoms.

Sampling Method

Non-Probability Sample

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D001526	Behavioral Symptoms