Phase 4
N=11
Intuniv vs Placebo in the Treatment of Childhood Intermittent Explosive Disorder
Intermittent Explosive Disorder · Childhood Aggression · Oppositional Defiant Disorder · Attention Deficit Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02048241 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Nov 2017
Primary outcome: Primary: Number of Participants That Were Responders — 0; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Parent Management Training (Behavioral); Placebo (Other); Intuniv (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants That Were Responders |
0; 5 | — |
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.
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 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 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
Data sourced from ClinicalTrials.gov (NCT02048241). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.