Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents (TEAM)
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.
Drug: Lithium carbonate
|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|
- 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.
- 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.
|Study Start Date:||February 2003|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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
Participants will receive treatment with valproate for 8 to 16 weeks
Titrated until blood level is 111 to 125 ug/mL
Other Name: Depakote
Participants will receive treatment with risperidone for 8 to 16 weeks
Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID
Other Name: Risperdal
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.
|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 in St. Louis|