Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
Condition: Autism
MeSH terms: Aggression; Autistic Disorder
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Aripiprazole; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Subjects under 40 kg will be started on 2.5mg per day of aripiprazole 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; Inactive tablet made to resemble active tablet
Subjects under 40 kg will be started on 2.5mg per day of 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 intervention name(s): Abilify; Placebo
Intervention MeSH terms: Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aggression; Irritability; Global autism severity