Bipolar Disorder in Epilepsy

NCT ID: NCT00365482

Last Updated: 2012-05-17

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

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-08-31

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.

The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center.

Detailed Description

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

Bipolar disorder (a condition of major mood swings) or milder forms of ups and downs in mood may occur with a number to neurological conditions. Recently, one study showed that these mood changes occur fairly often in individuals with epilepsy studied in the general community. We speculate that bipolar symptoms occur with even higher frequency in a tertiary epilepsy center than that encountered in the previous community-based study. The goals of this study are to assess:

* the rate of bipolar symptoms as measured by a self-reporting screening tool in a tertiary epilepsy center setting
* the meaning of a positive screening score in epilepsy patients
* the utility, sensitivity and specificity of alternative screening tools for mood instability in epilepsy patients
* the correlation of mood instability with seizure-related variables
* the relation of a positive screening score on quality of life.

Conditions

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

Epilepsy Bipolar Disorder

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

PROSPECTIVE

Eligibility Criteria

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

Inclusion Criteria

* Male or female 18 years of age or older
* Being evaluated at the Long Island Jewish Comprehensive Epilepsy Center
* Capable of completing self-reporting questionnaires

Exclusion Criteria

* Patients with mental retardation
* Patients with pseudoseizures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

Northwell Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sean Hwang, MD

Role: PRINCIPAL_INVESTIGATOR

Long Island Jewish Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

North Shore Long Island Jewish Health System

Great Neck, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06.02.029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cognitive Enhancement in Bipolar Disorder
NCT00597896 COMPLETED PHASE4