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Completed

NCT Number: NCT01085461

Assessment of Suicidality in Epilepsy - Rating Tools

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The International Center for Epilepsy (ICE) at the University of Miami, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

The Epilepsy Study Consortium

Other

Collaborators

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

Registry information

Acronym: ASERT

Important dates

Study start
2010
Study completion
2011
First posted
Mar 11, 2010
Registry last updated
Mar 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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