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Sponsored by: |
GlaxoSmithKline |
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Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00723450 |
The study will be a multi-center, parallel, group, placebo control, double-blind, randomized controlled trial of lamictal as add-on maintenance treatment in pediatric outpatients (aged 10 to 17 years) diagnosed with Bipolar I disorder. The study consists of 4 phases: Screen (approximately 2 weeks), Open label phase (up to 18 weeks), Randomized phase (up to 36 weeks) and Taper and follow-up phase (up to 4 weeks).
Condition | Intervention | Phase |
---|---|---|
Bipolar Disorder |
Drug: lamictal |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Evaluation of Lamictal as an Add-on Treatment for Bipolar I Disorder in Children and Adolescents, 10 to 17 Years of Age |
Estimated Enrollment: | 340 |
Study Start Date: | July 2008 |
Ages Eligible for Study: | 10 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
Study Director: | GSK Clinical Trials, MD | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | SCA102833 |
Study First Received: | July 24, 2008 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00723450 |
Health Authority: | United States: Food and Drug Administration |
Bipolar I
pediatric
lamictal
adolescent |
Calcium, Dietary Affective Disorders, Psychotic Mental Disorders Bipolar Disorder |
Lamotrigine Mood Disorders Psychotic Disorders |
Membrane Transport Modulators Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Calcium Channel Blockers Cardiovascular Agents Central Nervous System Agents Anticonvulsants Pharmacologic Actions |