Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With … (NCT00198107) | Clinical Trial Compass
CompletedPhase 3
Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
United States81 participantsStarted 2005-09
Plain-language summary
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Who can participate
Age range5 Years – 17 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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