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Treatment of Early Age Mania

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Treatment of Early Age Mania
Official Title  Treatment of Early Age Mania (TEAM) Study
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary Outcome Measure  Clinical Global Impressions-Bipolar [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Side Effects for Children and Adolescents [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: Yes ]
Mania Rating Scale [ Time Frame: Measured at Week 8 ] [ Designated as safety issue: No ]
Condition  Bipolar Disorder
Intervention  Drug: Lithium carbonate
Drug: Valproate
Drug: Risperidone
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  400
Start Date  February 2003
Completion Date December 2008
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
Gender Both
Ages 6 Years to 15 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Barbara Geller, MD         gellerb@medicine.wustl.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00057681
Organization ID U01 MH64846
Secondary IDs †† DDTR B4-ARM, U01 MH64851, U01 MH64911, U01 MH64868, U01 MH64887, U01 MH64850, U01 MH64869, DPTR B4-ARM
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Barbara Geller, MD     Washington University in St. Louis    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  April 4, 2003
Last Updated Date February 13, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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