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CompletedNCT01085461ASERTUpdated Mar 5, 2012

Assessment of Suicidality in Epilepsy - Rating Tools

An observational study in Epilepsy, sponsored by The Epilepsy Study Consortium. Completed at 6 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2012-03-05.

Sponsored by The Epilepsy Study Consortium · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
200
Ages
18 Years to 70 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Epilepsy

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In context

Epilepsy

1,805 studies on the registry are indexed under Epilepsy; 417 are open to participants now.

This study's planned enrollment of 200 is above the median of 102 across 521 observational studies indexed under Epilepsy.

Browse Epilepsy studies →

Lead sponsor

The Epilepsy Study Consortium is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
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.

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

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
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
200 participants (estimated)
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Study locations

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

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01085461
Lead sponsor
The Epilepsy Study Consortium
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
First posted
Mar 11, 2010
Start date
Jan 2010
Completion
Dec 2011
Last update
Mar 5, 2012

Study contacts

Jacqueline French, M.D.
principal investigator · NYU Langone Medical Center
Andres Kanner, M.D.
principal investigator · Rush University Medical Center
Dale Hesdorffer, PhD, MPH
principal investigator · Columbia University
Kelly Posner, PhD
principal investigator · Columbia University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.

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