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Awarded Trial: 06TGF-999
Grant ID
06TGF-999
Illness
Mania
Primary Drug/Intervention
Aripiprazole
Primary Dosage
15 mg
Secondary Drug Intervention
N/A
Secondary Dosage
N/A
Other Drug/Intervention
N/A
Other Dosage
N/A
Status
Completed
Investigator
Findling
Sample Size
50
Duration of Study Period for Each Subject
24 months
Outcome Measurements
Children's Depression Rating Scale, CGAS, CGI, YMRS
Results
Ninety-six (96) children ages 4-9 (mean age 6.9) with bipolar mania were treated with aripiprazole up to 15 mg/d for up to 16 wks in an open-label trial. Significant improvement was reported for YMRS, CDRS-R, CGAS, and CGI-S scores. The improvement was seen in 63 percent of the children, but the others did not respond.
Publication
Findling RL, Youngstrom EA, McNamara NK, et al. Double-Blind, Randomized, Placebo-Controlled Long-Term Maintenance Study of Aripiprazole in Children with Bipolar Disorder. J Clin Psychiatry 2012; 73:1.
Link
http://www.ncbi.nlm.nih.gov/pubmed/22152402
PI Name
Robert Findling
Degree
MD
Center
Case Western Reserve University, Child and Adolescent Psychiatry
Institution
University Hospitals of Cleveland
Address
11100 Euclid Avenue
City or Town
Cleveland
State or Province
OH
Zip or Postal Code
44106
Country
USA
Email Address
robert.findling@uhhs.com