Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Completed · Phase 3 · Has a placebo group
Conditions studied: Autistic Disorder
In brief
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Key facts
- Study ID
- NCT00198107
- Run by
- Indiana University
- People needed
- 81
- Starts
- 2005-09-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2019-04-09
Who can join
Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Riley Hospital for Children, Christian Sarkine Autism Treatment Center — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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