Back to resultsStudy of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM)
Primary Purpose
Bipolar Disorder
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lithium carbonate
Valproate
Risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder focused on measuring Mania
Eligibility 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
Sites / Locations
- Children's National Medical Center
- Johns Hopkins Medical Center
- Washington University School of Medicine
- University of Pittsburgh/WPIC
- University of Texas
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
1
2
3
Arm Description
Participants will receive treatment with lithium for 8 to 16 weeks
Participants will receive treatment with valproate for 8 to 16 weeks
Participants will receive treatment with risperidone for 8 to 16 weeks
Outcomes
Primary Outcome Measures
Clinical Global Impressions-Bipolar Mania Improvement
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
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
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.
Full Information
NCT ID
NCT00057681
First Posted
April 4, 2003
Last Updated
March 27, 2013
Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00057681
Brief Title
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Acronym
TEAM
Official Title
Treatment of Early Age Mania (TEAM) Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Mania
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
379 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Participants will receive treatment with lithium for 8 to 16 weeks
Arm Title
2
Arm Type
Experimental
Arm Description
Participants will receive treatment with valproate for 8 to 16 weeks
Arm Title
3
Arm Type
Experimental
Arm Description
Participants will receive treatment with risperidone for 8 to 16 weeks
Intervention Type
Drug
Intervention Name(s)
Lithium carbonate
Intervention Description
Titrated until blood level is 1.1 to 1.3 mEq/L
Intervention Type
Drug
Intervention Name(s)
Valproate
Other Intervention Name(s)
Depakote
Intervention Description
Titrated until blood level is 111 to 125 ug/mL
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
Primary Outcome Measure Information:
Title
Clinical Global Impressions-Bipolar Mania Improvement
Description
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.
Time Frame
Measured at Week 8
Secondary Outcome Measure Information:
Title
Modified Side Effects Form for Children and Adolescents
Description
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.
Time Frame
Measured at Week 8
Title
K-SADS Mania Rating Scale
Description
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.
Time Frame
Measured at Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Geller, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110-1093
Country
United States
Facility Name
University of Pittsburgh/WPIC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15208
Country
United States
Facility Name
University of Texas
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
18199241
Citation
Tillman R, Geller B, Klages T, Corrigan M, Bolhofner K, Zimerman B. Psychotic phenomena in 257 young children and adolescents with bipolar I disorder: delusions and hallucinations (benign and pathological). Bipolar Disord. 2008 Feb;10(1):45-55. doi: 10.1111/j.1399-5618.2008.00480.x.
Results Reference
background
PubMed Identifier
22213771
Citation
Geller B, Luby JL, Joshi P, Wagner KD, Emslie G, Walkup JT, Axelson DA, Bolhofner K, Robb A, Wolf DV, Riddle MA, Birmaher B, Nusrat N, Ryan ND, Vitiello B, Tillman R, Lavori P. A randomized controlled trial of risperidone, lithium, or divalproex sodium for initial treatment of bipolar I disorder, manic or mixed phase, in children and adolescents. Arch Gen Psychiatry. 2012 May;69(5):515-28. doi: 10.1001/archgenpsychiatry.2011.1508. Epub 2012 Jan 2.
Results Reference
result
PubMed Identifier
26598476
Citation
Walkup JT, Wagner KD, Miller L, Yenokyan G, Luby JL, Joshi PT, Axelson DA, Robb A, Salpekar JA, Wolf D, Sanyal A, Birmaher B, Vitiello B, Riddle MA. Treatment of Early-Age Mania: Outcomes for Partial and Nonresponders to Initial Treatment. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):1008-19. doi: 10.1016/j.jaac.2015.09.015. Epub 2015 Oct 8.
Results Reference
derived
PubMed Identifier
26598475
Citation
Salpekar JA, Joshi PT, Axelson DA, Reinblatt SP, Yenokyan G, Sanyal A, Walkup JT, Vitiello B, Luby JL, Wagner KD, Nusrat N, Riddle MA. Depression and Suicidality Outcomes in the Treatment of Early Age Mania Study. J Am Acad Child Adolesc Psychiatry. 2015 Dec;54(12):999-1007.e4. doi: 10.1016/j.jaac.2015.09.016. Epub 2015 Oct 8.
Results Reference
derived
PubMed Identifier
22917200
Citation
Vitiello B, Riddle MA, Yenokyan G, Axelson DA, Wagner KD, Joshi P, Walkup JT, Luby J, Birmaher B, Ryan ND, Emslie G, Robb A, Tillman R. Treatment moderators and predictors of outcome in the Treatment of Early Age Mania (TEAM) study. J Am Acad Child Adolesc Psychiatry. 2012 Sep;51(9):867-78. doi: 10.1016/j.jaac.2012.07.001. Epub 2012 Jul 31.
Results Reference
derived
PubMed Identifier
17335331
Citation
Tillman R, Geller B. Diagnostic characteristics of child bipolar I disorder: does the "Treatment of Early Age Mania (team)" sample generalize? J Clin Psychiatry. 2007 Feb;68(2):307-14. doi: 10.4088/jcp.v68n0218.
Results Reference
derived
Learn more about this trial
Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
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