Lithium for the Treatment of Pediatric Mania

PHASE2CompletedINTERVENTIONAL
Enrollment

61

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

April 30, 2009

Study Completion Date

September 30, 2009

Conditions
Bipolar I Disorder Without Psychotic Symptoms
Interventions
DRUG

Lithium Carbonate

The starting dose of lithium was 300 mg for patients weighing \< 20 kg

DRUG

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"

DRUG

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."

DRUG

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.

Trial Locations (1)

44126

CASE Western Reserve University, Cleveland

All Listed Sponsors
lead

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

NCT00442039 - Lithium for the Treatment of Pediatric Mania | Biotech Hunter | Biotech Hunter