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U.S. Department of Health and Human Services

Pediatric Studies Characteristics - Detail
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Approval Date:  03/24/2008
 
Trade Name:  Depakote ER Depakote Sprinkles
 
Generic or Proper Name (*):  divalproex disodium
 
Indications Studied:  Pediatric Bipolar Disorder; Prophylaxis of Migraine
 
Therapeutic Category:  Anticonvulsant; Mood Stablizer
 
Ages Studied:  10-17 years
 
Study #:  2
 
Study Type:  Efficacy
 
Study Design:  Single-Blind/Placebo/Parallel Group
 
No Patients:  144
 
No Centers:  24
 
No Countries:  1
 
BPCA(B), PREA(P):  B, P
 
Asian:  0
 
Black:  29
 
Other:  8
 
White:  107
 
Native Hawaiian or Pacific Islander:  0
 
American Indian/Alaska Native:  0
 
Hispanic/Latino:  0
 
Non-Hispanic/Non Latino:  0
 
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