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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: | NCT00178503 |
This study will first examine the cognitive and behavioral differences in children who have an autism spectrum disorder (ASD) and who do and do not have additional symptoms of attention deficit hyperactivity disorder (ADHD). The study will then examine the effectiveness of a range of doses of methylphenidate in improving cognitive and behavioral outcomes in children with both ASD and ADHD.
Condition | Intervention |
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Autism Attention Deficit Disorder With Hyperactivity |
Drug: Methylphenidate-extended release Drug: Methylphenidate-instant release Other: Placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | ADHD Symptoms in Autism: Cognition, Behavior, Treatment |
Estimated Enrollment: | 72 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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ASD/ADHD Group: No Intervention
Participants with autism and symptoms of ADHD who will undergo the initial psychological testing phase and will be compared to the autism-only group for behavioral, cognitive, and emotional differences
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ASD/non-ADHD group: No Intervention
Participants with autism and do not have symptoms of ADHD who will undergo the initial psychological testing phase and will be compared to the autism-ADHD group for behavioral, cognitive, and emotional differences
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MPH Trial-Placebo: Placebo Comparator
Participants with ASD-ADHD who will undergo 2 weeks of placebo in the MPH treatment phase
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Other: Placebo
Participants will take a placebo for 1 full week of the randomized drug trial. They will take one pill in the morning and one pill in the afternoon.
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MPH Trial: Low Dose: Active Comparator
Participants with ASD-ADHD who will undergo 1 week at a low dose of MPH in the MPH treatment phase
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Drug: Methylphenidate-extended release
Methylphenidate-extended release will be taken in the morning of the MPH treatment trial. Each participant will undergo 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will start at 10 mg Ritalin LA and will increase to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will start at 10 mg Ritalin LA and will increase to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will start at 20 mg Ritalin LA and will increase to 40 mg.
Drug: Methylphenidate-instant release
Methylphenidate-instant release will be taken in the evening. Each participant will undergo 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will take 2.5 mg IR-MPH and then 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will take 2 weeks of 5 mg IR-MPH and then 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will take 1 week of 5 mg IR-MPH and then 2 weeks of 10 mg.
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MPH Trial: Med Dose: Active Comparator
Participants with ASD-ADHD who will undergo 1 week at a medium dose of MPH in the MPH treatment phase
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Drug: Methylphenidate-extended release
Methylphenidate-extended release will be taken in the morning of the MPH treatment trial. Each participant will undergo 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will start at 10 mg Ritalin LA and will increase to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will start at 10 mg Ritalin LA and will increase to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will start at 20 mg Ritalin LA and will increase to 40 mg.
Drug: Methylphenidate-instant release
Methylphenidate-instant release will be taken in the evening. Each participant will undergo 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will take 2.5 mg IR-MPH and then 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will take 2 weeks of 5 mg IR-MPH and then 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will take 1 week of 5 mg IR-MPH and then 2 weeks of 10 mg.
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MPH Trial: High Dose: Active Comparator
Participants with ASD-ADHD who will undergo 1 week at a high dose of MPH in the MPH treatment phase
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Drug: Methylphenidate-extended release
Methylphenidate-extended release will be taken in the morning of the MPH treatment trial. Each participant will undergo 1 week of the each of the doses as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will start at 10 mg Ritalin LA and will increase to 20 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will start at 10 mg Ritalin LA and will increase to 30 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will start at 20 mg Ritalin LA and will increase to 40 mg.
Drug: Methylphenidate-instant release
Methylphenidate-instant release will be taken in the evening. Each participant will undergo 1 week at each of the 3 dose levels as determined by body weight. The lower body weight group (20 to 24 kg/44 to 52.8 lbs) will take 2.5 mg IR-MPH and then 2 weeks of 5 mg. The medium body weight group (25 to 33 kg/55 to 72.6 lbs) will take 2 weeks of 5 mg IR-MPH and then 1 week of 10 mg. The higher body weight group (34 to 59 kg/74.8 to 129.8 lbs) will take 1 week of 5 mg IR-MPH and then 2 weeks of 10 mg.
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Attention Deficit Hyperactivity Disorder (ADHD) is a major comorbid psychiatric disorder in children with Autism Spectrum Disorders (ASD) that significantly undermines behavioral, social, and emotional adjustment. Although the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) does not specifically allow for a comorbid diagnosis of ADHD with ASD, many children with an ASD manifest symptoms of ADHD and are treated for it with stimulants or other medication. The few studies on ADHD in ASD have not consistently established its cognitive and behavioral manifestations, or the optimal parameters for treatment. The proposed project will address these issues through studies of cognitive and behavioral functioning in children with ASD, with and without ADHD, and through a study of medication treatment of ADHD symptoms in autism.
Two groups of participants between the ages of 7 to 12 will participate in the initial phase of the study to examine the differences in children who have an Autism Spectrum Disorder with or without additional symptoms of ADHD. In one group, participants will qualify for a diagnosis of an Autism Spectrum Disorder (Autistic Disorder, Asperger's Disorder, and Pervasive Developmental Disorder-Not Otherwise Specified) and will also have symptoms of ADHD (ASD/ADHD), while in the second group, participants will have an Autism Spectrum Disorder, without symptoms of ADHD (ASD/non-ADHD group). All participants will undergo an initial psychological testing session that includes standardized measures of intellectual, adaptive behavior, language, behavioral, and emotional functioning, along with standardized diagnostic measures to confirm their diagnoses of ASD and/or ADHD (Visit 1). Children with intelligence quotients (IQs) below 50 or greater than 130 or with major sensory, motor, neurological, genetic, or psychiatric disorders that may interfere with testing will be excluded. The participants who meet eligibility criteria will complete computerized tasks of attentional functioning in a second visit (Visit 2).
A subset of the children from the ASD/ADHD group (N=24) will be invited to participate in a six-week randomized double-blind, placebo-controlled treatment trial using various doses (low, medium, or high dose) of methylphenidate (MPH). Children who are invited to participate in the treatment trial will be those who qualified based on the initial phase and who do not have any physical contraindications to MPH (e.g., history of MPH intolerance). In each week of the treatment trial, the child will take one of the three doses of MPH or a placebo. At the end of each week the child will be brought into the clinic by the parent for a medical check-up, parent interviews about the child's behavior and functioning that week, and computerized cognitive testing. Additionally, the child's parent and teacher will be asked to complete questionnaires about the child's behavior each week, so that the child's home and school behaviors at each MPH dose can be assessed.
Ages Eligible for Study: | 7 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Autism/ADHD Group:
Autism/non-ADHD Group:
Exclusion Criteria:
In both groups, exclusion criteria will include:
In the autism/ADHD group, further exclusion criteria apply to the MPH trial:
Contact: Rosleen Mansour, MA | 713-500-2580 | Rosleen.Mansour@uth.tmc.edu |
United States, Texas | |
University of Texas Health Science Center at Houston | Recruiting |
Houston, Texas, United States, 77030 | |
Contact: Rosleen Mansour, MA 713-500-2580 Rosleen.Mansour@uth.tmc.edu | |
Principal Investigator: Deborah A. Pearson, PhD | |
Sub-Investigator: Cynthia W. Santos, MD | |
Sub-Investigator: Katherine A. Loveland, PhD |
Principal Investigator: | Deborah A. Pearson, PhD | The University of Texas Health Science Center, Houston |
Responsible Party: | The University of Texas Health Science Center at Houston ( Deborah A. Pearson, PhD/Professor ) |
Study ID Numbers: | R01 MH72263, DDTR B2-NDA |
Study First Received: | September 12, 2005 |
Last Updated: | July 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00178503 |
Health Authority: | United States: Federal Government |
Developmental Disabilities Attention Deficit and Disruptive Behavior Disorders Methylphenidate Dyskinesias Child Development Disorders, Pervasive Signs and Symptoms Dopamine |
Attention Deficit Disorder with Hyperactivity Autistic Disorder Mental Disorders Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations |
Dopamine Uptake Inhibitors Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Disease Molecular Mechanisms of Pharmacological Action Nervous System Diseases Physiological Effects of Drugs |
Central Nervous System Stimulants Pharmacologic Actions Pathologic Processes Therapeutic Uses Dopamine Agents Central Nervous System Agents |