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

Completed · Phase 3

Conditions studied: Bipolar Disorder

In brief

This study will evaluate the effectiveness of the medications, lithium (Eskalith®), valproate (Depakote®), and risperidone (Risperdal®) in treating children and adolescents with bipolar disorder or symptoms of mania.

Key facts

Study ID

NCT00057681

Run by

Washington University School of Medicine

People needed

379

Starts

2003-02-01

Expected to finish

2008-12-01

Last updated by the study team

2013-04-04

Who can join

Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks
• CGAS less than or equal to 60
• Good physical health

You may not qualify if…

• Schizophrenia or any pervasive developmental disorder
• Major medical or neurological disease
• History of addiction to illicit substances or alcohol or drug abuse within the last 4 weeks
• IQ less than 70
• Pregnancy or breast-feeding
• Unacceptable methods of contraception
• In-patient care at baseline

Where it is running

• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Pittsburgh/WPIC — Pittsburgh, Pennsylvania, United States
• University of Texas — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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