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Assessment of Suicidality in Epilepsy - Rating Tools (ASERT)

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ClinicalTrials.gov Identifier: NCT01085461
Recruitment Status : Completed
First Posted : March 11, 2010
Last Update Posted : March 5, 2012
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

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 11, 2010
Last Update Posted Date March 5, 2012
Study Start Date January 2010
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01085461 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Assessment of Suicidality in Epilepsy - Rating Tools
Official Title Assessment of Suicidality in Epilepsy - Rating Tools
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Epilepsy
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Estimated Enrollment
 (submitted: March¬†10,¬†2010)
200
Original Estimated Enrollment Same as current
Actual Study Completion Date December 2011
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01085461
Other Study ID Numbers TESC-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jacqueline French, MD, The Epilepsy Study Consortium
Study 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
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
PRS Account The Epilepsy Study Consortium
Verification Date March 2012