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

The Washington University

Status and phase: Completed; Phase 3

Conditions: Bipolar Disorder

Treatments: Drug: Valproate; Drug: Lithium carbonate; Drug: Risperidone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00057681

U01MH064887 (U.S. NIH Grant/Contract)

U01MH064846-06

U01MH064846 (U.S. NIH Grant/Contract)

U01MH064869 (U.S. NIH Grant/Contract)

U01MH064850 (U.S. NIH Grant/Contract)

U01MH064868 (U.S. NIH Grant/Contract)

U01MH064911 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 379 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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379 participants in 3 patient groups

1

Experimental group

Description:

Participants will receive treatment with lithium for 8 to 16 weeks

Treatment:

Drug: Lithium carbonate

2

Experimental group

Description:

Participants will receive treatment with valproate for 8 to 16 weeks

Treatment:

Drug: Valproate

3

Experimental group

Description:

Participants will receive treatment with risperidone for 8 to 16 weeks

Treatment:

Drug: Risperidone