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

March 27, 2013 updated by: Washington University School of Medicine

Treatment of Early Age Mania (TEAM) Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

379

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medical Center
    • Missouri
      • St. Louis, Missouri, United States, 63110-1093
        • Washington University School of Medicine
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15208
        • University of Pittsburgh/WPIC
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured at Week 8
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.
Measured at Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Barbara Geller, MD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

April 4, 2003

First Submitted That Met QC Criteria

April 4, 2003

First Posted (Estimate)

April 8, 2003

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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