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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00365482
Other study ID # 06.02.029
Secondary ID
Status Completed
Phase N/A
First received August 15, 2006
Last updated May 15, 2012
Start date August 2006
Est. completion date December 2011

Study information

Verified date May 2012
Source Northwell Health
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 102
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States North Shore Long Island Jewish Health System Great Neck New York

Sponsors (2)

Lead Sponsor Collaborator
Northwell Health GlaxoSmithKline

Country where clinical trial is conducted

United States, 

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