Assessment of Suicidality in Epilepsy - Rating Tools (ASERT)

March 1, 2012 updated by: The Epilepsy Study Consortium

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • The International Center for Epilepsy (ICE) at the University of Miami
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush Epilepsy Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital, Adult Epilepsy Center
    • New York
      • New York, New York, United States, 10016
        • NYU Comprehensive Epilepsy Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Jefferson Comprehensive Epilepsy Center
      • Philadelphia, Pennsylvania, United States, 19104
        • The Penn Epilepsy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with partial epilepsy for at least two years, who are treatment resistant, experience at least 1 seizure/month, and are receiving 1-3 AEDs/month will be selected.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Epilepsy Study Consortium

Collaborators

UCB Pharma
GlaxoSmithKline
Pfizer
H. Lundbeck A/S
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Eisai Inc.
Supernus Pharmaceuticals, Inc.
Upsher-Smith Laboratories

Investigators

  • Principal Investigator: Jacqueline French, M.D., NYU Langone Medical Center
  • Principal Investigator: Andres Kanner, M.D., Rush University Medical Center
  • Principal Investigator: Dale Hesdorffer, PhD, MPH, Columbia University
  • Principal Investigator: Kelly Posner, PhD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

March 10, 2010

First Submitted That Met QC Criteria

March 10, 2010

First Posted (Estimate)

March 11, 2010

Study Record Updates

Last Update Posted (Estimate)

March 5, 2012

Last Update Submitted That Met QC Criteria

March 1, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TESC-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Epilepsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe