Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder

Completed · Phase 4 · Has a placebo group

Conditions studied: Intermittent Explosive Disorder, Childhood Aggression, Oppositional Defiant Disorder, Attention Deficit Disorder

In brief

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.

Key facts

Study ID

NCT02048241

Run by

New York State Psychiatric Institute

People needed

11

Starts

2011-07-01

Expected to finish

2014-12-01

Last updated by the study team

2018-06-13

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• New York State Psychiatric Institute — New York, New York, United States

Full record on ClinicalTrials.gov

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