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
  Purpose

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 Intervention Phase
Bipolar Disorder
Drug: Lithium carbonate
Drug: Valproate
Drug: Risperidone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Early Age Mania (TEAM) Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 379
Study Start Date: February 2003
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   6 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057681

Locations
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
Investigators
Principal Investigator: Barbara Geller, MD Washington University School of Medicine
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00057681     History of Changes
Other Study ID Numbers: U01 MH64846-06, U01MH064846, U01MH064911, U01MH064868, U01MH064887, U01MH064850, U01MH064869
Study First Received: April 4, 2003
Results First Received: May 29, 2012
Last Updated: March 27, 2013
Health Authority: United States: Federal Government

Keywords provided by Washington University School of Medicine:
Mania

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Valproic Acid
Lithium Carbonate
Lithium
Risperidone
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Antipsychotic Agents
Antidepressive Agents
Serotonin Antagonists
Serotonin Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on August 01, 2014