Autistic Disorder | Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Autistic Disorder research study
What is the primary objective of this study?
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:AripiprazoleParticipants will receive 8 weeks of initial treatment with aripiprazole. If responsive to treatment, participants may be assigned to an additional 16 weeks of aripiprazole and then an additional 8 more weeks of aripiprazole with D-cycloserine. Dosing schedule for participants less than 50 kg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
Drug:PlaceboParticipants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
Drug:D-cycloserineD-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
1 PlaceboParticipants will take placebo
2 AripiprazoleParticipants will take aripiprazole
3 Aripiprazole + D-cycloserineParticipants first will take aripiprazole then will also take D-cycloserine
Start Date: September 2005
Completed Date: September 2011
Phase: Phase 3
Primary Outcome: Mean Post-baseline Aberrant Behavior Checklist Irritability Score, Parent Report, Double-blind Phase
Secondary Outcome: Mean Post-baseline Aberrant Behavior Checklist Hyperactivity Score, Parent Report, Double-blind Phase
Study sponsors, principal investigator, and references
Principal Investigator: Christopher J. McDougle, MD
Lead Sponsor: Indiana University
Collaborator: National Institute of Mental Health (NIMH)