Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism

• Status: Completed
• Trial end date: 2011-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Aripiprazole; Cycloserine

Criteria

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