Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00057681
First received: April 4, 2003
Last updated: March 27, 2013
Last verified: March 2013

April 4, 2003
March 27, 2013
February 2003
December 2008   (final data collection date for primary outcome measure)
Clinical Global Impressions-Bipolar Mania Improvement [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00057681 on ClinicalTrials.gov Archive Site
  • Modified Side Effects Form for Children and Adolescents [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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.
Not Provided
Not Provided
Not Provided
 
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Bipolar Disorder
  • Drug: Lithium carbonate
    Titrated until blood level is 1.1 to 1.3 mEq/L
  • Drug: Valproate
    Titrated until blood level is 111 to 125 ug/mL
    Other Name: Depakote
  • Drug: Risperidone
    Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
    Other Name: Risperdal
  • Experimental: 1
    Participants will receive treatment with lithium for 8 to 16 weeks
    Intervention: Drug: Lithium carbonate
  • Experimental: 2
    Participants will receive treatment with valproate for 8 to 16 weeks
    Intervention: Drug: Valproate
  • Experimental: 3
    Participants will receive treatment with risperidone for 8 to 16 weeks
    Intervention: Drug: Risperidone

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
379
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00057681
U01 MH64846-06, U01MH064846, U01MH064911, U01MH064868, U01MH064887, U01MH064850, U01MH064869
Yes
Washington University School of Medicine
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Principal Investigator: Barbara Geller, MD Washington University School of Medicine
Washington University School of Medicine
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP