Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder (NCT02048241) | Clinical Trial Compass
CompletedPhase 4
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
United States11 participantsStarted 2011-07
Plain-language 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.
Who can participate
Age range6 Years β 12 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. Age 6-12
β. Meets DSM-IV TR Criteria for Intermittent Explosive Disorder
β. several discreet episodes of failure to resist aggressive impulses that result in serious assaultive acts or destruction of property
β. the degree of aggressiveness is grossly out of proportion to any precipitating psychosocial stressors
β. the aggressive episode is not better accounted for by another mental disorder
β. duration of at least six months
β. impairment in home, peer relations and / or school