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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00057681
Recruitment Status : Completed
First Posted : April 8, 2003
Results First Posted : March 27, 2013
Last Update Posted : April 4, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Bipolar Disorder Drug: Lithium carbonate Drug: Valproate Drug: Risperidone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 379 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Early Age Mania (TEAM) Study
Study Start Date : February 2003
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
Participants will receive treatment with lithium for 8 to 16 weeks
Drug: Lithium carbonate
Titrated until blood level is 1.1 to 1.3 mEq/L

Experimental: 2
Participants will receive treatment with valproate for 8 to 16 weeks
Drug: Valproate
Titrated until blood level is 111 to 125 ug/mL
Other Name: Depakote

Experimental: 3
Participants will receive treatment with risperidone for 8 to 16 weeks
Drug: Risperidone
Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
Other Name: Risperdal

Primary Outcome Measures :
  1. Clinical Global Impressions-Bipolar Mania Improvement [ Time Frame: Measured at Week 8 ]
    The Clinical Global Impressions-Bipolar (CGI-BP) assessment instrument measured improvement in mania, depression, and overall bipolar illness. The primary outcome measure was mania improvement, which measured the change in mania from baseline. Scores were 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse.

Secondary Outcome Measures :
  1. Modified Side Effects Form for Children and Adolescents [ Time Frame: Measured at Week 8 ]
    The Modified Side Effects Form for Children and Adolescents includes 62 potential side effects, with measures of frequency and severity for each item. Frequencies are 0=not present, 1=1-2 days, 2=3-4 days, 3=5-7 days. Severity scores are 0=not present, 1=mild (does not interfere with functioning), 2=moderate (some interference with functioning), 3=severe (functioning is significantly impaired because of side effects). Items for cardiovascular, gastrointestinal, central nervous system, ocular, mouth and nose, genito urinary, dermatology, musculo-skeletal, and other side effects are included. For analyses, side effects that were reported at any frequency and a severity of 2 or greater were considered present.

  2. K-SADS Mania Rating Scale [ Time Frame: Measured at Week 8 ]
    The K-SADS Mania Rating Scale (KMRS) is comprised of 15 items modified from WASH-U-KSADS items. The individual items are scored on a 1-6 severity scale and then these item scores are summed to create an overall KMRS score. Guidelines for interpretation are as follows: 0-11 = no or minimal mania, 12-17 = mild mania, 18-25 = moderate mania, 26+ = marked or worse mania. The maximum possible score is 64.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00057681

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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20010
United States, Maryland
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110-1093
United States, Pennsylvania
University of Pittsburgh/WPIC
Pittsburgh, Pennsylvania, United States, 15208
United States, Texas
University of Texas
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
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Principal Investigator: Barbara Geller, MD Washington University School of Medicine
Publications of Results:
Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine Identifier: NCT00057681    
Other Study ID Numbers: U01MH064846-06 ( U.S. NIH Grant/Contract )
U01MH064846 ( U.S. NIH Grant/Contract )
U01MH064911 ( U.S. NIH Grant/Contract )
U01MH064868 ( U.S. NIH Grant/Contract )
U01MH064887 ( U.S. NIH Grant/Contract )
U01MH064850 ( U.S. NIH Grant/Contract )
U01MH064869 ( U.S. NIH Grant/Contract )
First Posted: April 8, 2003    Key Record Dates
Results First Posted: March 27, 2013
Last Update Posted: April 4, 2013
Last Verified: March 2013
Keywords provided by Washington University School of Medicine:
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antidepressive Agents
Enzyme Inhibitors
Antimanic Agents
GABA Agents