Depakote (Divalproex Sodium) for Children With Temper Dysregulation and Severe Mood Swings
Status:
Completed
Trial end date:
2004-03-01
Target enrollment:
Participant gender:
Summary
Though the Disruptive Disorders of Childhood and Adolescence are a major source of morbidity
and fill a large proportion of special education slots, specific pharmacologic treatment is
available only for those children with Attention Deficit/Hyperactivity Disorder. Other
disruptive children are usually said to "have" Oppositional Defiant or Conduct Disorder.
These diagnoses are useful descriptively but they do not have specific treatment implications
In the course of treating adolescents with explosive tempers and severe mood swings with
Depakote (divalproex sodium), the investigators learned that younger children manifest
symptoms that seemed identical to those constituting the adolescent disorder. They were in
special education programs and not responding to psychostimulants.
The investigators systematically collected data on these children using the same screening
criteria as in our studies of adolescents. Since Depakote has been used to treat seizures in
children for more than twenty years, a great deal was known about its safety profile in the
pediatric population. The investigators treated 7 children, age 7-12, whose recurrent temper
outbursts and chronic mood lability did not respond to individual/family therapy. After
parents signed informed consent and children gave assent, these subjects would receive open
label Depakote in doses sufficient to reach a blood level between 50-100 micrograms/ml for
six weeks. The family received supportive therapy.