Bipolar Disorder in Epilepsy
| Tracking Information | |||||
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| First Received Date ICMJE | August 15, 2006 | ||||
| Last Updated Date | May 15, 2012 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00365482 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bipolar Disorder in Epilepsy | ||||
| Official Title ICMJE | Bipolar Disorder in Epilepsy | ||||
| Brief Summary | The purpose of this study is to find out how often major mood swings occur in patients treated in a specialty epilepsy center. |
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| 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:
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Epilepsy patients at the Long Island Jewish Comprehensive Epilepsy Center |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 102 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00365482 | ||||
| Other Study ID Numbers ICMJE | 06.02.029 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | North Shore Long Island Jewish Health System | ||||
| Study Sponsor ICMJE | North Shore Long Island Jewish Health System | ||||
| Collaborators ICMJE | GlaxoSmithKline | ||||
| Investigators ICMJE |
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| Information Provided By | North Shore Long Island Jewish Health System | ||||
| Verification Date | May 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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