Efficacy of Aripiprazole Versus Placebo in the Reduction of Aggressive and Aberrant Behavior in Autistic Children
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Autism |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 5 - 17 |
| Updated: | 10/14/2017 |
| Start Date: | May 2006 |
| End Date: | November 2009 |
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.
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.
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.
We found this trial at
1
site
671 Hoes Lane West
Piscataway, New Jersey 08854
Piscataway, New Jersey 08854
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