Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

PHASE4CompletedINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 31, 2005

Primary Completion Date

February 29, 2008

Study Completion Date

April 30, 2008

Conditions
Bipolar DisorderMania
Interventions
DRUG

lamotrigine

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.

Trial Locations (1)

02138

Massachusetts General Hospital, Cambridge

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER

NCT00181844 - Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder | Biotech Hunter | Biotech Hunter