Assessment of Suicidality in Epilepsy - Rating Tools

Completed

Conditions studied: Epilepsy

In brief

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.

Key facts

Study ID

NCT01085461

Run by

The Epilepsy Study Consortium

People needed

200

Starts

2010-01-01

Expected to finish

2011-12-01

Last updated by the study team

2012-03-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Partial epilepsy for at least two years, confirmed with EEG studies
• Aged 18 to 70 years-old
• Proficient in English
• Having a minimum of a 4th grade reading level
• Having been on stable doses and type of AEDs for the previous two months
• Have at least 1 observable partial seizure (simple partial with motor component, complex partial or secondarily generalized tonic clonic seizure) per month for the past 6 months
• Is currently receiving 1-3 AEDs
• Has failed at least 2 AEDs (including current therapy)

You may not qualify if…

• Non-epileptic seizures with or without comorbid epileptic seizures
• Subjects who currently carry a diagnosis of a major psychotic disorder
• Subjects who are currently taking an investigational medication
• Subjects with a known history of alcoholism, drug abuse, or drug addiction within the past 2 years

Where it is running

• The International Center for Epilepsy (ICE) at the University of Miami — Miami, Florida, United States
• Rush Epilepsy Center — Chicago, Illinois, United States
• Johns Hopkins Hospital, Adult Epilepsy Center — Baltimore, Maryland, United States
• NYU Comprehensive Epilepsy Center — New York, New York, United States
• The Penn Epilepsy Center — Philadelphia, Pennsylvania, United States
• Jefferson Comprehensive Epilepsy Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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