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Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

Treatment of Early Age Mania (TEAM) Study

NCT00057681•Washington University School of Medicine

View on ClinicalTrials.gov

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.

Detailed Description

Patients are randomly assigned to receive lithium (Eskalith), valproate (Depakote), or risperidone (Risperdal) for 8 to 16 weeks. They will have weekly visits to monitor their response to the medication. When the study is complete, care will be transferred to the child's treating psychiatrist.

Eligibility

Age

6 - 15 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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

Locations (5)

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

Key Dates

Start Date

February 1, 2003

Primary Completion Date

December 1, 2008

Completion Date

December 1, 2008

Last Updated

April 4, 2013

Enrollment

379

ACTUAL participants

Conditions

Bipolar Disorder

Interventions

Lithium carbonate

DRUG

Valproate

DRUG

Risperidone

DRUG

University of Iowa Interventional Psychiatry Service Patient Registry

NCT04480918

Treatment Resistant DepressionMajor Depressive Episode+5 more

View study

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913

ManiaBipolar Disorder

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 4, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

University of Iowa Interventional Psychiatry Service Patient Registry

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Epigenetic Enhancement of Cognitive Training in Aging Mood Disorder Populations

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A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

Early Intervention for Youth at High Risk for Bipolar Disorder