Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Intervention: Aripiprazole; Placebo; D-cycloserine
Intervention description: Participants 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.; Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.; D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
Intervention MeSH terms: Cycloserine; Aripiprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 81.0
Sex: All
Minimum age: 5 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Children; Adolescents; Aripiprazole; Cycloserine; Aggression; Irritability; Self-Injurious Behavior; Social Interaction; Antipsychotics; Pharmacology; Glutamatergic Agents

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

Eligibility 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