EpilepsyASERTNCT01085461
Assessment of Suicidality in Epilepsy - Rating Tools
An observational study of Epilepsy, run by The Epilepsy Study Consortium at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Epilepsy
- How many people
- 200 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2010to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Johns Hopkins Hospital, Adult Epilepsy Center
Baltimore, Maryland, 21287
Rush Epilepsy Center
Chicago, Illinois, 60612
The International Center for Epilepsy (ICE) at the University of Miami
Miami, Florida, 33136
NYU Comprehensive Epilepsy Center
New York, New York, 10016
The Penn Epilepsy Center
Philadelphia, Pennsylvania, 19104
Jefferson Comprehensive Epilepsy Center
Philadelphia, Pennsylvania, 19107
About this study
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.
- Conditions
- Epilepsy
- Medical subject headings
- Epilepsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study startJan 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Epilepsy Study Consortium
- Sponsor type
- University, hospital or other
- 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
- Jacqueline French, M.D., Principal investigator, NYU Langone Medical CenterAndres Kanner, M.D., Principal investigator, Rush University Medical CenterDale Hesdorffer, PhD, MPH, Principal investigator, Columbia UniversityKelly Posner, PhD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085461
- Sponsor's protocol ID
- TESC-002
- Acronym
- ASERT
- Status last verified
- Mar 2012
- First submitted
- 10 Mar 2010
- Last updated
- 5 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Suicidality in Epilepsy - Rating Tools
- ClinicalTrials.gov ID
- NCT01085461
- Acronym / sponsor ID
- ASERT / TESC-002
- Conditions
- Epilepsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Epilepsy Study ConsortiumUniversity, hospital or other
- 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
- Study start
- Jan 2010
- Study completion
- Dec 2011 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2012.
- The Epilepsy Study ConsortiumLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by The Epilepsy Study Consortium at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2012.