Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM)
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ClinicalTrials.gov Identifier: NCT00057681 |
Recruitment Status :
Completed
First Posted : April 8, 2003
Results First Posted : March 27, 2013
Last Update Posted : April 4, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Bipolar Disorder | Drug: Lithium carbonate Drug: Valproate Drug: Risperidone | Phase 3 |
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 |
- 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.
- 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.
- 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.

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00057681
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 |
Principal Investigator: | Barbara Geller, MD | Washington University School of Medicine |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Washington University School of Medicine |
ClinicalTrials.gov 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 |
Mania |
Bipolar Disorder Bipolar and Related Disorders Mental Disorders Valproic Acid Risperidone 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 Anticonvulsants GABA Agents |