Status:
COMPLETED
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Lead Sponsor:
Indiana University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Autistic Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE3
Brief Summary
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Detailed Description
Autism is a developmental disorder that affects every child differently. A wide range of symptoms accompany autism, including self-injurious behavior, aggression, and severe tantrums. Despite an impro...
Eligibility Criteria
Inclusion
- Weight of at least 15 kg (33.75 lbs)
- Meets DSM-IV criteria for autistic disorder
- Outpatient
- Medication-free for at least 2 weeks prior to baseline for all psychotropic medications. More information about this criterion, including exceptions, can be found in the protocol.
- Clinical Global Impression Scale Severity score (CGI-S) of at least 4
- Irritability subscale of the Aberrant Behavior Checklist (ABC) score of at least 18
- An IQ of at least 35 or a mental age of at least 18 months
- In good physical health
Exclusion
- Meets DSM-IV criteria for Asperger's disorder, Rett's disorder, childhood disintegrative disorder, any other pervasive developmental disorder (PDD), schizophrenia, psychotic disorder, or bipolar disorder
- Current or past history of alcohol or other substance abuse within 6 months of study entry
- Comorbid neurodevelopmental disorder with possible association to autism (e.g., fragile-X syndrome, tuberous sclerosis)
- A significant medical condition such as heart, liver, kidney, or lung disease, or a seizure disorder
- Pregnant
- Prior adequate use of aripiprazole. More information about this criterion can be found in the protocol.
- Evidence of hypersensitivity to aripiprazole
- History of neuroleptic malignant syndrome
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00198107
Start Date
September 1 2005
End Date
September 1 2011
Last Update
April 9 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Riley Hospital for Children, Christian Sarkine Autism Treatment Center
Indianapolis, Indiana, United States, 46202