61
Participants
Start Date
December 31, 2006
Primary Completion Date
April 30, 2009
Study Completion Date
September 30, 2009
Lithium Carbonate
The starting dose of lithium was 300 mg for patients weighing \< 20 kg
Lithium Carbonate
"The dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability. The starting dose of lithium was 900 mg and the dose of lithium was increased weekly by 300 mg to maximum tolerated dose depending upon the patients response and tolerability"
Lithium Carbonate
"The starting dose of lithium was 900 mg and the lithium dose was increased by 300 mg every 3 days, (no more than twice weekly) to maximum tolerated dose based upon the patients response and tolerability."
Placebo
During the third phase, which is the Discontinuation Phase, patients will be randomized to either placebo or lithium treatment for up to 28 weeks.
CASE Western Reserve University, Cleveland
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH