|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT01085461 |
|
Date of registration:
|
10/03/2010 |
|
Primary sponsor: |
|
|
Public title:
|
Assessment of Suicidality in Epilepsy - Rating Tools
ASERT |
|
Scientific title:
|
Assessment of Suicidality in Epilepsy - Rating Tools |
|
Date of first enrolment:
|
January 2010 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT01085461 |
|
Study type:
|
Observational |
|
Study design:
|
Observational Model: Case-Only, Time Perspective: Cross-Sectional
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Dale Hesdorffer, PhD, MPH |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Columbia University |
|
|
Name:
|
Kelly Posner, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Columbia University |
|
|
Name:
|
Jacqueline French, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
NYU Langone Medical Center |
|
|
Name:
|
Andres Kanner, M.D. |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Rush University Medical Center |
| | |
|
Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
|
Epilepsy
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|