Clinical trial NCT01085461: Assessment of Suicidality in Epilepsy - Rating Tools
Official title: Assessment of Suicidality in Epilepsy - Rating Tools
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: The Epilepsy Study Consortium
Sponsor class: OTHER
Collaborators: name: Eisai Inc.
name: GlaxoSmithKline
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: H. Lundbeck A/S
name: Pfizer
name: Supernus Pharmaceuticals, Inc.
name: UCB Pharma
name: Upsher-Smith Laboratories
First posted: 2010-03-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: The International Center for Epilepsy (ICE) at the University of Miami
state: Florida
city: Chicago
country: United States
facility: Rush Epilepsy Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Hospital, Adult Epilepsy Center
state: Maryland
city: New York
country: United States
facility: NYU Comprehensive Epilepsy Center
state: New York
city: Philadelphia
country: United States
facility: The Penn Epilepsy Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Jefferson Comprehensive Epilepsy Center
state: Pennsylvania
Study officials:
affiliation: NYU Langone Medical Center
name: Jacqueline French, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rush University Medical Center
name: Andres Kanner, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Dale Hesdorffer, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Columbia University
name: Kelly Posner, PhD
role: PRINCIPAL_INVESTIGATOR
References: