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| Tracking Information | |||||||||
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| First Received Date ICMJE | September 13, 2005 | ||||||||
| Last Updated Date | April 24, 2007 | ||||||||
| Start Date ICMJE | August 2005 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00223509 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Secondary measures will include the YMRS, and CGI Bipolar version. | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Lamictal As Add on Treatment in Mixed States of Bipolar Disorder | ||||||||
| Official Title ICMJE | Lamictal As Add on Treatment in Mixed States of Bipolar Disorder | ||||||||
| Brief Summary |
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| Detailed Description |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
| Condition ICMJE | Bipolar Disorder | ||||||||
| Intervention ICMJE | Drug: Lamotrigine | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 50 | ||||||||
| Estimated Completion Date | October 2010 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: In order to be included in the study patient must meet criteria A, C, D, E, F, G plus any 1 of the 3 criteria listed in section B. A. Patients meeting DSM-IV diagnosis of bipolar disorder, I or II B.
C.MADRS of ≥14 D.YMRS of ≥ 14 E. Age 13years to 75 years F. Male or female G. Outpatient Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 13 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00223509 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 0340013418 | ||||||||
| Study Sponsor ICMJE | The University of Texas Health Science Center at San Antonio | ||||||||
| Collaborators ICMJE | GlaxoSmithKline | ||||||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center at San Antonio | ||||||||
| Verification Date | April 2007 | ||||||||
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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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