Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-31 @ 7:33 AM
Study NCT ID:
NCT01085461
Status:
COMPLETED
Last Update Posted:
2012-03-05
First Post:
2010-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Suicidality in Epilepsy - Rating Tools
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-01', 'studyFirstSubmitDate': '2010-03-10', 'studyFirstSubmitQcDate': '2010-03-10', 'lastUpdatePostDateStruct': {'date': '2012-03-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-11', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.epilepsyconsortium.org', 'label': 'The Epilepsy Study Consortium'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Partial epilepsy for at least two years, confirmed with EEG studies\n* Aged 18 to 70 years-old\n* Proficient in English\n* Having a minimum of a 4th grade reading level\n* Having been on stable doses and type of AEDs for the previous two months\n* 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\n* Is currently receiving 1-3 AEDs\n* Has failed at least 2 AEDs (including current therapy)\n\nExclusion criteria:\n\n* Non-epileptic seizures with or without comorbid epileptic seizures\n* Subjects who currently carry a diagnosis of a major psychotic disorder\n* Subjects who are currently taking an investigational medication\n* Subjects with a known history of alcoholism, drug abuse, or drug addiction within the past 2 years'}, 'identificationModule': {'nctId': 'NCT01085461', 'acronym': 'ASERT', 'briefTitle': 'Assessment of Suicidality in Epilepsy - Rating Tools', 'organization': {'class': 'OTHER', 'fullName': 'The Epilepsy Study Consortium'}, 'officialTitle': 'Assessment of Suicidality in Epilepsy - Rating Tools', 'orgStudyIdInfo': {'id': 'TESC-002'}}, 'contactsLocationsModule': {'locations': [{'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'The International Center for Epilepsy (ICE) at the University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush Epilepsy Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital, Adult Epilepsy Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Comprehensive Epilepsy Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'The Penn Epilepsy Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Jefferson Comprehensive Epilepsy Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Jacqueline French, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Medical Center'}, {'name': 'Andres Kanner, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}, {'name': 'Dale Hesdorffer, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}, {'name': 'Kelly Posner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Epilepsy Study Consortium', 'class': 'OTHER'}, 'collaborators': [{'name': 'Eisai Inc.', 'class': 'INDUSTRY'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}, {'name': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.', 'class': 'INDUSTRY'}, {'name': 'H. Lundbeck A/S', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Supernus Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, {'name': 'UCB Pharma', 'class': 'INDUSTRY'}, {'name': 'Upsher-Smith Laboratories', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Jacqueline French, MD', 'oldOrganization': 'The Epilepsy Study Consortium'}}}}