Clinical trial NCT00057681: Study of Outcome and Safety of Lithium, Divalproex and Risperidone for Mania in Children and Adolescents
Official title: Treatment of Early Age Mania (TEAM) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Mania
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-08
Enrollment: 379
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinical Global Impressions-Bipolar Mania Improvement
timeFrame: Measured at Week 8
Secondary outcomes:
measure: Modified Side Effects Form for Children and Adolescents
timeFrame: Measured at Week 8
measure: K-SADS Mania Rating Scale
timeFrame: Measured at Week 8
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Pittsburgh
country: United States
facility: University of Pittsburgh/WPIC
state: Pennsylvania
city: Galveston
country: United States
facility: University of Texas
state: Texas
Study officials:
affiliation: Washington University School of Medicine
name: Barbara Geller, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.