Assessment of Suicidality in Epilepsy - Rating Tools

Epilepsy Clinical Trial

— ASERT  

Official title:

Assessment of Suicidality in Epilepsy - Rating Tools

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01085461
• Other study ID #: TESC-002
• Status: Completed
• Phase: N/A
• First received: March 10, 2010
• Last updated: March 1, 2012
• Start date: January 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: The Epilepsy Study Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

• 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)

Exclusion criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Epilepsy

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital, Adult Epilepsy Center	Baltimore	Maryland
United States	Rush Epilepsy Center	Chicago	Illinois
United States	The International Center for Epilepsy (ICE) at the University of Miami	Miami	Florida
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

Sponsors (9)

Lead Sponsor	Collaborator
The Epilepsy Study Consortium	Eisai Inc., GlaxoSmithKline, H. Lundbeck A/S, Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Pfizer, Supernus Pharmaceuticals, Inc., UCB Pharma, Upsher-Smith Laboratories

Country where clinical trial is conducted

United States, 

External Links

•   The Epilepsy Study Consortium