Assessment of Suicidality in Epilepsy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY

NCT03419000

Drug Resistant Epilepsy

COMPLETED NA

Human Epilepsy Project 3

NCT05374928

Idiopathic Generalized Epilepsy

ACTIVE_NOT_RECRUITING

Investigating Epilepsy: Screening and Evaluation

NCT03478852

Seizures Epilepsy Epilepsy, Temporal Lobe +1 more

RECRUITING

Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset Seizures

NCT01191086

Epilepsy

COMPLETED PHASE3

Retigabine (Adjunctive Therapy) Efficacy and Safety Study for Partial Onset Refractory Seizures in Epilepsy

NCT00232596

Seizures

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No