Clinical trial NCT00198107
Conditions: Autistic Disorder
Keywords: Children Adolescents Aripiprazole Cycloserine Aggression Irritability Self-Injurious Behavior Social Interaction Antipsychotics Pharmacology Glutamatergic Agents
Sponsor: Indiana University
Start date: 2005-09-01; Completion date: 2011-09-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Participants will take placebo arm 2: Participants will take aripiprazole arm 3: Participants first will take aripiprazole then will also take D-cycloserine
Interventions: intervention 1: Aripiprazole intervention 2: Placebo intervention 3: D-cycloserine
Intervention descriptions: intervention 1: 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. intervention 2: Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment. intervention 3: D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.

Protocol documents: