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

NCT00057681 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 379

Last updated 2013-04-04

Study results available
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Summary

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.

Conditions

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Barbara Geller, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-02-28
Primary Completion
2008-12-31
Completion
2008-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00057681 on ClinicalTrials.gov