Assessment of Suicidality in Epilepsy - Rating Tools (ASERT)

This study has been completed.
Sponsor:
Collaborators:
Eisai Inc.
GlaxoSmithKline
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
H. Lundbeck A/S
Pfizer
Supernus Pharmaceuticals, Inc.
UCB Pharma
Upsher-Smith Laboratories
Information provided by:
The Epilepsy Study Consortium
ClinicalTrials.gov Identifier:
NCT01085461
First received: March 10, 2010
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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.


Condition
Epilepsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Assessment of Suicidality in Epilepsy - Rating Tools

Resource links provided by NLM:


Further study details as provided by The Epilepsy Study Consortium:

Estimated Enrollment: 200
Study Start Date: January 2010
Study Completion Date: December 2011
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01085461

Locations
United States, Florida
The International Center for Epilepsy (ICE) at the University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Rush Epilepsy Center
Chicago, Illinois, United States, 60612
United States, Maryland
Johns Hopkins Hospital, Adult Epilepsy Center
Baltimore, Maryland, United States, 21287
United States, New York
NYU Comprehensive Epilepsy Center
New York, New York, United States, 10016
United States, Pennsylvania
Jefferson Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, United States, 19107
The Penn Epilepsy Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
The Epilepsy Study Consortium
Eisai Inc.
GlaxoSmithKline
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
H. Lundbeck A/S
Pfizer
Supernus Pharmaceuticals, Inc.
UCB Pharma
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
  More Information

Additional Information:
No publications provided

Responsible Party: Jacqueline French, MD, The Epilepsy Study Consortium
ClinicalTrials.gov Identifier: NCT01085461     History of Changes
Other Study ID Numbers: TESC-002
Study First Received: March 10, 2010
Last Updated: March 1, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2014