Evaluating the Effectiveness of Aripiprazole and D-Cycloserine to Treat Symptoms Associated With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 3

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

Detailed description: 
      Autism is a developmental disorder that affects every child differently. A wide range of
      symptoms accompany autism, including self-injurious behavior, aggression, and severe
      tantrums. Despite an improved ability to reduce these symptoms, existing drug treatments
      continue to be associated with adverse side effects. Also, there is no existing drug
      treatment that reliably improves social behavior, a core deficit in autism. Studies on drug
      treatment combinations that are designed to reduce self-injurious behavior, aggression, and
      severe tantrums and improve social behavior in children with autism have yet to be conducted.
      This study will address the above-mentioned limitations by evaluating aripiprazole in
      reducing self-injurious behavior, aggression, and severe tantrums and by evaluating the
      addition of D-Cycloserine in improving social behavior among children with autism.

      This study will include three phases and an add-on component for some children. Participants
      will be randomly assigned to receive either aripiprazole or a placebo treatment for 8 weeks.
      Assessments measuring irritability, behavior, and social skills will be conducted at the end
      of this first phase. Those patients who respond well to aripiprazole will continue to receive
      aripiprazole treatment for another 16 weeks. This second phase will determine whether
      aripiprazole is associated with long-term maintenance of symptomatic improvement in patients
      who respond well to short-term treatment. Assessments will again be conducted at the end of
      this 16-week period. Those patients whose symptoms have stabilized and continue to improve
      while on aripiprazole will be asked to participate in the final phase of this study. During
      the this pilot phase, D-Cycloserine will be added to ongoing treatment with aripiprazole.
      Patients will take both aripiprazole and D-Cycloserine for an additional 8 weeks to determine
      if this combination of drug treatments results in improved social behavior once patients'
      aggression and self-injurious behavior have been stabilized with aripiprazole. At the end of
      this 8-week period, participants will be assessed for any changes in behavior, irritability,
      or social skills. Results from this study may aid in developing safer and more effective drug
      treatments for children and adolescents with autism.
    

Intervention name(s): Aripiprazole; Placebo; D-cycloserine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 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.
Other intervention name(s): Abilify
Intervention MeSH terms: Cycloserine; Aripiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Children; Adolescents; Aripiprazole; Cycloserine; Aggression; Irritability; Self-Injurious Behavior; Social Interaction; Antipsychotics; Pharmacology; Glutamatergic Agents