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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00198107 |
This study will determine the effectiveness of aripiprazole and D-Cycloserine in treating symptoms associated with autism in children.
Condition | Intervention | Phase |
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Autistic Disorder |
Drug: Aripiprazole Drug: Placebo Drug: D-cycloserine Other: fMRI |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Novel Pharmacological Strategies in Autism |
Estimated Enrollment: | 88 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Participants will take placebo
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Drug: Placebo
Participants assigned to placebo will take a placebo pill for the initial 8 weeks of treatment.
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2: Active Comparator
Participants will take aripiprazole
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Drug: Aripiprazole
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 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
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3: Active Comparator
Participants first will take aripiprazole then will also take D-cycloserine
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Drug: Aripiprazole
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 mg maximum dose will be 10 mg per day. Dosing schedule for participants greater than 50 kg maximum dose will be 15 mg.
Drug: D-cycloserine
D-cycloserine will be dosed in the range of 25 to 200 mg daily for the final 8 weeks of treatment.
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Add-on Study
To conduct a double-blind, placebo-controlled fMRI study of brain activation and connectivity patterns before and after aripiprazole with 20 subjects who enter the Study A Phase.
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Other: fMRI
Subjects will undergo an fMRI and a facial affect processing task.
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Autism is a developmental disability that affects every child differently. A wide range of symptoms accompany autism, including self-injurious behavior, severe aggression, and irritability. 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, the core deficit in autism. Studies on drug treatment combinations that are designed to reduce self-injurious behavior, aggression, and irritability 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 irritability 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 last phase, D-Cycloserine will be added to the treatment regimen. 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.
Add-study: The Effects of Aripiprazole on Brain Circuitry in Children and Adolescents with Autism
The purpose of this added phase is to conduct a double-blind, placebo-controlled fMRI study of brain activation and connectivity patterns before and after aripiprazole treatment with 20 subjects who enter Study phase A. Children must be able to comply with the fMRI scan and a facial affect processing task. The child must have the ability to lie still during the scanning procedures and to comply with instructions. The aim is to determine the effects of aripiprazole treatment on amygdalar activation in response to a negative facial emotional task vs. a neutral (control) task. We that hypothesize that compared to placebo, aripiprazole treatment will increase amygdalar activation in response to a negative facial emotion task. In addition we hypothesize that increases in amygdalar activation will positively correlate with improvement on behavioral rating scales.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Arlene E. Kohn, BA | 317-274-1990 | aekohn@iupui.edu |
Contact: Marianna Zaphiriou | 317-278-6253 | mzaphiri@iupui.edu |
United States, Indiana | |
Riley Hospital for Children, Christian Sarkine Autism Treatment Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Arlene E. Kohn, BA | |
Principal Investigator: Christopher J. McDougle, MD |
Principal Investigator: | Christopher J. McDougle, MD | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( Christopher J. McDougle, MD ) |
Study ID Numbers: | R01 MH072961, DSIR 82-SEDR |
Study First Received: | September 12, 2005 |
Last Updated: | August 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00198107 |
Health Authority: | United States: Federal Government |
Children Adolescents Aripiprazole Cycloserine Aggression Irritability |
Self-Injurious Behavior Social Interaction Antipsychotics Pharmacology Glutamatergic Agents |
Cycloserine Developmental Disabilities Child Development Disorders, Pervasive Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Aripiprazole Aggression Self-Injurious Behavior |
Antimetabolites Anti-Infective Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Psychotropic Drugs Central Nervous System Depressants Anti-Infective Agents, Urinary |
Renal Agents Antipsychotic Agents Pharmacologic Actions Antibiotics, Antitubercular Anti-Bacterial Agents Therapeutic Uses Antitubercular Agents Central Nervous System Agents |