Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children (Abilify)
Hypothesis: (1) Aripiprazole treatment will be superior to placebo in reducing aggression and irritability in autistic individuals as shown by reductions in the Aberrant Behavior Checklist-irritability subscale.
(2) Aripiprazole treatment will be superior to placebo in the acute treatment of global autism severity.
The purpose of this study is to examine the possible benefit of the medication Aripiprazole in autistic individuals.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children|
- Clinical Global Impression Improvement (CGI-AD) [ Time Frame: Administered weekly ] [ Designated as safety issue: No ]
- Aberrant Behavior Checklist [ Time Frame: Administered weekly ] [ Designated as safety issue: No ]
- Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: Administered every 4 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Study Completion Date:||November 2009|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Subjects in the experimental group will receive Aripiprazole
Subjects under 40 kg will be started on 2.5mg per day of aripiprazole or placebo for the first week and increased to 5 mg at week 2. If clinically indicated (partial improvement with minimal or no side effects), the dosage will be increased each week by 2.5 mg until they reach a maximum of 10 mg at week 4. Medication will not be increased after week four but may be lowered in the case of adverse effects. Subjects over 40 kg will start at 5 mg and be increased to 10 mg at week 2. If clinically indicated, they will be increased each week by 5 mg until they reach a maximum of 20 mg at week 4. After week 4, the subject will remain on the same stable dose, unless the dose needs to be decreased due to adverse effects
Other Name: Abilify
Placebo Comparator: Placebo
Subjects in the control group will receive placebo
Subjects in the control group will receive placebo in the same dosage as the active drug
Aripiprazole is an atypical antipsychotic medication which is currently approved for the treatment of schizophrenia in adults. Multiple clinical trials in both children and adults have shown the effectiveness in the treatment of autism with medications like Aripiprazole. This study aims at assessing the effect of aripiprazole vs. placebo treatment on symptoms of irritability and aggression associated with autism, as well as the effect on the global severity of child and adolescent autistic disorder. Children or adolescent outpatients, with age ranges from 5-17, will be enrolled into an 8-week placebo controlled, double blind treatment study. During the 8 weeks, patients will be monitored by the treating psychiatrist. Study assessments will be administered at designated time points.
|United States, New Jersey|
|Department of Child and Adolescent Psychiatry, University Behavioral Health Care Building|
|Piscataway, New Jersey, United States, 08854|
|Principal Investigator:||Sherie L. Novotny, MD||Child and Adolescent Psychiatry, UMDNJ|