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Intermittent Explosive Disorder | Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder

Intermittent Explosive Disorder research study

What is the primary objective of this study?

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 is eligible to participate?

Inclusion Criteria: 1. Age 6-12 2. Meets DSM-IV TR Criteria for Intermittent Explosive Disorder 1. several discreet episodes of failure to resist aggressive impulses that result in serious assaultive acts or destruction of property 2. the degree of aggressiveness is grossly out of proportion to any precipitating psychosocial stressors 3. the aggressive episode is not better accounted for by another mental disorder 4. duration of at least six months 5. impairment in home, peer relations and / or school 3. Modified Overt Aggression Scale (MOAS) score > 15 4. Parent and child willing to consent to study 5. Inadequate response to psycho-social interventions (including school interventions) 6. Medically healthy with 1. weight > 55 lb (25 kg) 2. body mass index < 35 3. normal blood pressure as defined by National Heart Lung and Blood Institute (below 95th percentile for age height and weight) 4. normal response to orthostatic changes (no persistent fall in systolic/diastolic BP > 20/10 mm Hg within 3 minutes of assuming the upright position) 5. normal electrocardiogram 6. normal vital signs 7. no history of intolerance of guanfacine. 7. 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: 1. Current Treatment with another alpha 2 blocker e.g. clonidine 2. Puberty 3. Meets criteria for Pervasive Developmental Disorder or Childhood schizophrenia 4. MOAS score > 50 5. weight < 55 lb or body mass index > 35 6. hypertension (Blood Pressure above 95th percentile for age height and weight) 7. Chronic hypotension (Blood Pressure at or below 5th percentile for age height and weight) 8. Orthostatic Hypotension fall in systolic/diastolic BP > 20/10 mm Hg within 3 minutes of assuming the upright position 9. QTc interval of > 440 milliseconds; Bradycardia; heart block diagnosed 10. history of seizure during the past 2 years (exclusive of febrile seizures) 11. Patients who had taken an investigational drug within 28 days 12. Intelligence Quotient < 70 13. Physical exam, EKG or laboratory results with any other significant abnormalities until reviewed by medicine. 14. Active suicidal or homicidal ideation or history of suicide attempts 15. Unequivocal manic or hypomanic Episode 16. Patients who meet criteria for Major Depression in pre-puberty will not be eligible for this study. 17. 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. 18. Any other history of cardiovascular dysfunction 19. Positive Urine Toxicology 20. Children who have experienced prior adverse effects (physical or psychological) to either Tenex or clonidine 21. Any child who previously received Tenex and either did not tolerate it, or failed to respond to an adequate trial

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Intermittent Explosive Disorder

Childhood Aggression

Oppositional Defiant Disorder

Attention Deficit Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:Parent Management TrainingThis 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.

Other:PlaceboWeekly dispensation of pills matching Intuniv but without the active medication

Drug:IntunivWeekly administration of medication in doses as per protocol

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Placebo plus Parent Management TrainingPills matching Intuniv Tablets without active medication combined with weekly Parent Management Training

Intuniv plus Parent Management TrainingAdministration 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

Study Status

Completed

Start Date: July 2011

Completed Date: December 2014

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Number of Participants That Were Responders

Secondary Outcome: Percent Change in Score on the Attention Deficit Hyperactivity Disorder [ADHD] Rating Scale

Study sponsors, principal investigator, and references

Principal Investigator: Stephen J Donovan, MD

Lead Sponsor: New York State Psychiatric Institute

Collaborator: Shire

More information:https://clinicaltrials.gov/show/NCT02048241

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