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Treatment of Early Age Mania



Treatment of Early Age Mania

For Condition: Manic Disorder,Bipolar Disorder
Status: Recruiting
Sponsor(s): National Institute of Mental Health (NIMH) ,
Synopsis: The purpose of this study is to evaluate the effectiveness of the drugs lithium, valproate, and risperidone in treating children and adolescents with bipolar disorder or symptoms of mania.
Details: 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:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 6 Years/14 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria: - DSM-IV criteria for bipolar I (manic or mixed) or mania for at least 4 weeks - CGAS <= 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 < 70 - Pregnancy or breast-feeding - Unacceptable methods of contraception - In-patient care at baseline
Total Enrollment: 540

Location and Contact Information:

University of Texas *Recruiting*
Galveston,  Texas, 
United States
Recruiting Candice  Hausler 281-335-5403

University of Pittsburgh/WPIC *Recruiting*
Pittsburgh,  Pennsylvania, 
United States
Recruiting Annette  Baughman 800-518-0370

Children's National Medical Center *Recruiting*
Washington D.C.,  District of Columbia, 
United States
Recruiting Helena  Boothe 202-884-2681

Johns Hopkins Medical Center *Recruiting*
Baltimore,  Maryland, 
United States
Recruiting Sam  Walford 410-955-1542

University of Texas Southwestern Medical Center *Recruiting*
Dallas,  Texas, 
United States
Recruiting Judith  Hume 214-456-2416

Washington University School of Medicine *Recruiting*
St. Louis,  Missouri, 
United States
Recruiting Samantha  Blankenship 314-286-2783


Additional Information:
Study ID Numbers:
  1RO1MH064846-01 A1;  64850,64851,64887,64868,64911,64869
Study Start Date: February 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057681

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