NCT00057681View on ClinicalTrials.gov

Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents

PHASE3CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

February 28, 2003

Primary Completion Date

December 31, 2008

Study Completion Date

December 31, 2008

Conditions
Bipolar Disorder
Interventions
DRUG

Lithium carbonate

Titrated until blood level is 1.1 to 1.3 mEq/L

DRUG

Valproate

Titrated until blood level is 111 to 125 ug/mL

DRUG

Risperidone

Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Trial Locations (5)

15208

University of Pittsburgh/WPIC, Pittsburgh

20010

Children's National Medical Center, Washington D.C.

21287

Johns Hopkins Medical Center, Baltimore

77555

University of Texas, Galveston

63110-1093

Washington University School of Medicine, St Louis

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Washington University School of Medicine

OTHER

NCT00057681 - Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents | Biotech Hunter | Biotech Hunter