EpilepsyNCT00365482
Bipolar Disorder in Epilepsy
An observational study of Epilepsy and Bipolar Disorder, run by Northwell Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsy, Bipolar Disorder
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Epilepsy patients at the Long Island Jewish Comprehensive Epilepsy Center
Who may be able to join
- 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
Who cannot join
- Patients with mental retardation
- Patients with pseudoseizures
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore Long Island Jewish Health System
Great Neck, New York, 11021
About this study
The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center.
Read the detailed 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.
- Conditions
- Epilepsy, Bipolar Disorder
- Keywords
- Epilepsy, Bipolar Disorder
- Medical subject headings
- Epilepsy, Bipolar Disorder
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2006 (estimated)
- Study startAug 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Sean Hwang, MD, Principal investigator, Long Island Jewish Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00365482
- Sponsor's protocol ID
- 06.02.029
- Status last verified
- May 2012
- First submitted
- 15 Aug 2006
- Last updated
- 17 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Disorder in Epilepsy
- ClinicalTrials.gov ID
- NCT00365482
- Acronym / sponsor ID
- 06.02.029
- Conditions
- Epilepsy, Bipolar Disorder
- Keywords
- Epilepsy, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Aug 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 17 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Epilepsy patients at the Long Island Jewish Comprehensive Epilepsy Center
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patients with mental retardation
- Patients with pseudoseizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2012.
Related trials for Epilepsy
RecruitingPhase 3
Study of NRTX-1001 Neural Cell Therapy in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (EPIC (EPIlepsy Cell Therapy))
Mesial Temporal Lobe Epilepsy
RecruitingObservational study
Electrocardiographic Changes Associated With Epilepsy
ECG Changes
Recruiting
Combined CM and STN Stimulation for Motor Epilepsy
Motor Epilepsy
Not yet recruiting
Lily's Grace Temporal Interference
Epilepsy
Not yet recruiting
Characterisation of Laryngeal Evoked Potentials Induced by Vagus Nerve Stimulation in Refractory Epilepsy Patients
Refractory Epilepsy, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Hwang, MD principal investigator
Long Island Jewish Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy and Bipolar Disorder, run by Northwell Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2012.