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

Bipolar Disorder Clinical Trial

— TEAM  

Official title:

Treatment of Early Age Mania (TEAM) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057681
• Other study ID #: U01MH064846-06
• Secondary ID: U01MH064846U01MH
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2003
• Last updated: March 27, 2013
• Start date: February 2003
• Est. completion date: December 2008

Study information

• Verified date: March 2013
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 379
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 15 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Lithium carbonate
Titrated until blood level is 1.1 to 1.3 mEq/L
• Valproate
Titrated until blood level is 111 to 125 ug/mL
• Risperidone
Titrated by weight until dose is 2.0 mg BID to 3.0 mg BID

Locations

Country	Name	City	State
United States	Johns Hopkins Medical Center	Baltimore	Maryland
United States	University of Texas	Galveston	Texas
United States	University of Pittsburgh/WPIC	Pittsburgh	Pennsylvania
United States	Washington University School of Medicine	St. Louis	Missouri
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 fo — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured at Week 8	No
Secondary	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.	Measured at Week 8	Yes
Secondary	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.	Measured at Week 8	No