Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children

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.

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.

Inclusion Criteria:

• Meets DSM-IV, ADI-R criteria for autistic disorder.
• Age 5-17 years.
• Outpatients
• Parent or legal guardian willing to sign informed consent.

Exclusion Criteria:

• Subject has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression).
• Subject has caused visible harm to him/herself.
• Subject has an active seizure disorder or epilepsy (seizures within the past year).
• Subject has an unstable medical illness, including heart disease.
• Subject has experienced brain injury.
• Subject has a history of diabetes.
• Subject reports significant improvement of autism symptoms and behaviors to current medication or other therapies.
• Subject has a history of prior treatment with Aripiprazole of 5 mg/day or higher for 6 weeks.
• Subject lives in a far away area and/or does not have regular access to transportation to the clinical facility.
• Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.