NCT00855725

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

1 year

First QC Date

March 3, 2009

Last Update Submit

July 8, 2009

Conditions

Keywords

EpilepsyDepressionNeurologyfMRIHealthy Controls

Interventions

fMRIOTHER

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Healthy adults of 18 years of age or older.

You may not qualify if:

  • 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
  • Subject is at least 18 years of age
  • Subject has confirmed temporal lobe epilepsy (TLE)
  • 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
  • Subject is at least 18 years of age
  • +15 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Shore LIJ Health System

Manhasset, New York, 11030, United States

Location

MeSH Terms

Conditions

EpilepsyDepression

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesBehavioral SymptomsBehavior

Study Officials

  • Alan Ettinger, M.D.

    Northwell Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 4, 2009

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations