Assessment of Suicidality in Epilepsy - Rating Tools

NCT01085461 | Completed

• 1 other identifier: TESC-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Epilepsy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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

Sponsors & Collaborators

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

Study Sites (6)

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

Miami, Florida, 33136, United States

Location

Rush Epilepsy Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Hospital, Adult Epilepsy Center

Baltimore, Maryland, 21287, United States

Location

NYU Comprehensive Epilepsy Center

New York, New York, 10016, United States

Location

The Penn Epilepsy Center

Philadelphia, Pennsylvania, 19104, United States

Location

Jefferson Comprehensive Epilepsy Center

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• The Epilepsy Study Consortium

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: January 1, 2010
• Study Completion: December 1, 2011
• Last Updated: March 5, 2012

Record last verified: 2012-03

Locations

US (6)