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Assessment of Suicidality in Epilepsy - Rating Tools

Completed
Conditions
Epilepsy
Registration Number
NCT01085461
Lead Sponsor
The Epilepsy Study Consortium
Brief Summary

This will be a cross-sectional study enrolling 200 outpatients/inpatients with treatment resistant partial epilepsy for at least two years, receiving 1-3 AEDS.

The study will consist of one or two visits, each lasting 1-2 hours. All subjects will complete Visit 1. Twenty five percent of the subjects will return for Visit 2. The study will assess the prevalence of depression and suicidal thoughts and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy (PWE) who may be ineligible for future trials.

Detailed Description

In light of the recent issues regarding antiepileptic drugs and suicidality, The Epilepsy Study Consortium is proposing a pilot study. Several scales to assess suicidality and screen for depression and anxiety disorders will be administered to a group of epilepsy patients with characteristics similar to patients who are usually enrolled in epilepsy clinical trials. The study will assess the prevalence of depression, suicidal thoughts, and behavior and the feasibility of using the proposed psychiatric rating scales in future epilepsy clinical trials. This study will also provide an estimate of the proportion of patients with epilepsy who may be ineligible for future trials because they have had active suicidal thoughts in the last 6 months, suicidal behavior in the last 2 years or a current major depressive episode.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (6)

The International Center for Epilepsy (ICE) at the University of Miami

🇺🇸

Miami, Florida, United States

Johns Hopkins Hospital, Adult Epilepsy Center

🇺🇸

Baltimore, Maryland, United States

Rush Epilepsy Center

🇺🇸

Chicago, Illinois, United States

NYU Comprehensive Epilepsy Center

🇺🇸

New York, New York, United States

Jefferson Comprehensive Epilepsy Center

🇺🇸

Philadelphia, Pennsylvania, United States

The Penn Epilepsy Center

🇺🇸

Philadelphia, Pennsylvania, United States

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