Assessment of Suicidality in Epilepsy - Rating Tools

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01085461

Acronym

ASERT

Enrollment

200

Registered

2010-03-11

Start date

2010-01-31

Completion date

2011-12-31

Last updated

2012-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Countries

United States

Outcome results