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| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00360126 |
Purpose
The precursor study (SCA101469) was an open-label, prospective multicentre study in adult subjects diagnosed with bipolar disorder consisting of 36 weeks treatment with lamotrigine. The current study is to provide 12 months post study access to open-label lamotrigine for participants of the SCA101469 study.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder |
Drug: lamotrigine |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | An Open-Label Extension Study to Assess the Safety of Lamotrigine in Subjects With Bipolar Disorder, Who Are in Remission Following a Manic/Hypomanic Index Episode or a Depressive Index Episode. |
| Estimated Enrollment: | 15 |
| Study Start Date: | October 2005 |
| Study Completion Date: | February 2007 |
| Primary Completion Date: | February 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
A subject will be eligible for inclusion in this study only if all of the following criteria apply:
A female is eligible to enter and participate in this study if she is of:
child-bearing potential, has a negative urine pregnancy test at screening, and agrees to one of the following contraceptive methods:
Barrier method only if used in combination with any of the above acceptable methods.
Exclusion Criteria:
A subject will not be eligible for inclusion in this study if any of the following criteria apply:
Contacts and Locations| Australia, New South Wales | |
| GSK Investigational Site | |
| Greenwich, New South Wales, Australia, 2065 | |
| Australia, Queensland | |
| GSK Investigational Site | |
| Everton Park, Queensland, Australia, 4053 | |
| GSK Investigational Site | |
| New Farm, Queensland, Australia, 4005 | |
| Study Director: | GSK Clinical Trials, MBBS MRCP | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | SCA104753 |
| Study First Received: | August 2, 2006 |
| Last Updated: | October 15, 2008 |
| ClinicalTrials.gov Identifier: | NCT00360126 History of Changes |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Bipolar Disorder lamotrigine Lamictal Open-Label Extension Study |
|
Disease Molecular Mechanisms of Pharmacological Action Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Pharmacologic Actions Membrane Transport Modulators Affective Disorders, Psychotic |
Pathologic Processes Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Central Nervous System Agents Anticonvulsants |