Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Open Study of the Safety and Effectiveness of Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar I, Bipolar II, and Bipolar Spectrum Disorders|
- Change of Mania Symptoms Assessed by Young Mania Rating Scale (YMRS) [ Time Frame: baseline to 12 weeks ] [ Designated as safety issue: No ]Mean reduction in YMRS score at endpoint/LOCF. This is a scale to measure symptoms of mania in children and adolescents. 11 items are rated from 0-4 (7 items) or 0-8 (4 items). The minimum (least severe) total score is 0, and maximum (most severe) total score is 60.
|Study Start Date:||January 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||February 2008 (Final data collection date for primary outcome measure)|
Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
Other Name: Lamictal
Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania,& mixed episodes) in patients treated for acute mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance treatment was more robust in bipolar depression.
The study includes 1) use of a 12-week design to document the response rate 2) assessment of the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of safety and tolerability.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00181844
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Janet Wozniak, MD||Massachusetts General Hospital|