Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
Status:
Completed
Trial end date:
2014-12-01
Target enrollment:
Participant gender:
Summary
Children with explosive aggression are often rejected by their peers, placed in special
classroom, and contribute to family discord. When psychotherapy and family therapy is
unsuccessful, medications are often used. Current medications are stimulants (e.g.
methylphenidate, dextroamphetamine), anticonvulsants (e.g. Divalproex) and antipsychotics
(olanzapine, risperidone). At this time, the available medications are of limited usefulness,
either because they do not always work or because they have side effects such as weight gain
or insomnia. There is a clear need for new medications to treat explosive aggression when
psychotherapy is unsuccessful.
The hypothesis of this study is the medication Intuniv when combined with psychotherapy will
be more helpful to children with explosive aggression than placebo combined with
psychotherapy. Intuniv is a long acting form of guanfacine, a medication approved by the FDA
for treatment of Attention Deficit Hyperactivity Disorder. Intuniv is not a stimulant, nor is
it an anticonvulsant, nor is it an antipsychotic.
The children in this study will be between the ages of 6 and 12 and meet Diagnostic and
Statistical Manual of Psychiatry Fourth Edition, Text Revision (DSM-IV-TR) criteria for
Intermittent Explosive Disorder.