Intervention: Guanfacine Hydrochloride
Trial phase: Phase 4
SMILES: Cl.NC(N)=NC(=O)Cc1c(Cl)cccc1Cl
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 6
Group description: Administration of Intuniv in increasing doses from 1 mg to 2 mgs to 3 mgs to 4 mgs as tolerated over a period of 4-6 weeks, combined with weekly Parent Management Training

Parent Management Training: This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.

Intuniv: Weekly administration of medication in doses as per protocol
Eligibility criteria:
Inclusion Criteria:

Age 6-12

Meets DSM-IV TR Criteria for Intermittent Explosive Disorder

several discreet episodes of failure to resist aggressive impulses that result in serious assaultive acts or destruction of property
the degree of aggressiveness is grossly out of proportion to any precipitating psychosocial stressors
the aggressive episode is not better accounted for by another mental disorder
duration of at least six months
impairment in home, peer relations and / or school
Modified Overt Aggression Scale (MOAS) score > 15
Parent and child willing to consent to study
Inadequate response to psycho-social interventions (including school interventions)

Medically healthy with

weight > 55 lb (25 kg)
body mass index < 35
normal blood pressure as defined by National Heart Lung and Blood Institute (below 95th percentile for age height and weight)
normal response to orthostatic changes (no persistent fall in systolic/diastolic BP > 20/10 mm Hg within 3 minutes of assuming the upright position)
normal electrocardiogram
normal vital signs
no history of intolerance of guanfacine.
If on another medication, willingness to discontinue if medication is judged ineffective after adequate trial or to remain on a constant optimized dose if it is partially effective

Exclusion Criteria:

Current Treatment with another alpha 2 blocker e.g. clonidine
Puberty
Meets criteria for Pervasive Developmental Disorder or Childhood schizophrenia
MOAS score > 50
weight < 55 lb or body mass index > 35
hypertension (Blood Pressure above 95th percentile for age height and weight)
Chronic hypotension (Blood Pressure at or below 5th percentile for age height and weight)
Orthostatic Hypotension fall in systolic/diastolic BP > 20/10 mm Hg within 3 minutes of assuming the upright position
QTc interval of > 440 milliseconds; Bradycardia; heart block diagnosed
history of seizure during the past 2 years (exclusive of febrile seizures)
Patients who had taken an investigational drug within 28 days
Intelligence Quotient < 70
Physical exam, EKG or laboratory results with any other significant abnormalities until reviewed by medicine.
Active suicidal or homicidal ideation or history of suicide attempts
Unequivocal manic or hypomanic Episode
Patients who meet criteria for Major Depression in pre-puberty will not be eligible for this study.
Axis I disorders that are current, severe and uncontrolled. Children with moderate Axis I pathology will be evaluated on a case by case basis and excluded if the other diagnosis is not ADHD but could still be the cause of the temper dyscontrol and the treatment is judged substandard.
Any other history of cardiovascular dysfunction
Positive Urine Toxicology
Children who have experienced prior adverse effects (physical or psychological) to either Tenex or clonidine
Any child who previously received Tenex and either did not tolerate it, or failed to respond to an adequate trial