Effectiveness of Atomoxetine in Treating Attention Deficit Hyperactivity Disorder Symptoms in Children and Adolescents With Autism - Full Text View

Sponsored by:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00498173

Purpose

This study will evaluate the effectiveness of atomoxetine in treating children with attention deficit hyperactivity disorder symptoms associated with autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified.

Condition	Intervention	Phase
Autism	Drug: Atomoxetine Drug: Placebo	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder Autism

Drug Information available for: Atomoxetine Atomoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Targeted Pharmacologic Interventions for Autism: A Double-Blind, Placebo-Controlled Trial of Atomoxetine in Children and Adolescents With Autism

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

ADHD symptoms [ Time Frame: Measured at Weeks 1 through 4, 6, and 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Irritability and anxiety [ Time Frame: Measured at Weeks 1 through 4, 6, and 8 ] [ Designated as safety issue: Yes ]
Core autistic symptoms [ Time Frame: Measured at Weeks 1 through 4, 6, and 8 ] [ Designated as safety issue: No ]
Quality of life [ Time Frame: Measured at Weeks 1 through 4, 6, and 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	86
Study Start Date:	July 2007
Estimated Study Completion Date:	July 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive atomoxetine for 8 weeks	Drug: Atomoxetine Available tablet strengths of atomoxetine: 5 mg, 10 mg, 25 mg, 40 mg. Week 1 participant takes 0.5 mg/kg/day, Week 2: 0.8 mg/kg/day, Week 3: 1.2 mg/kg/day. Potential exists for dose increase at Week 4 to 1.8 mg/kg/day based on clinical global impression-improvement rating at Week 4.
2: Placebo Comparator Participants will receive placebo for 8 weeks	Drug: Placebo Placebo tablets dosages: 5 mg, 10 mg, 25 mg, 40 mg.

Detailed Description:

Autism is a developmental disorder that can cause severe and pervasive impairment in thinking, feeling, language, and the ability to relate to others. It is usually first diagnosed in early childhood. Children with autism demonstrate repetitive behaviors or interests and deficits in social interaction, verbal communication, and nonverbal communication. In addition, they often have unusual responses to sensory experiences, such as certain sounds or the way objects look. Some symptoms of attention deficit hyperactivity disorder (ADHD), such as inattention, hyperactivity, and impulsivity, are also associated with autism. Atomoxetine is a selective norepinephrine reuptake inhibitor that is used to treat ADHD. It works differently, however, than stimulant drugs and may help to reduce ADHD symptoms in children with autism. This study will evaluate the effectiveness of atomoxetine in treating children with ADHD symptoms associated with autism.

Potential participants will first attend a screening visit, which will include a psychiatric diagnostic interview, a practice session for swallowing pill capsules, a physical exam, an electrocardiogram (ECG), a blood test, and an assessment of pubertal stage. Females of childbearing age will also undergo a urine pregnancy test. In an initial double-blind study phase, eligible participants will be randomly assigned to receive either atomoxetine or placebo for 8 weeks. A baseline visit will include several rating scales, observations, and an interview to assess adaptive functioning. These measures and procedures will be used to keep track of symptoms, side effects, and behavior that could change during the study. Children who are assigned to placebo and do not notice an improvement in their ADHD symptoms will be given the opportunity to receive atomoxetine at the end of 8 weeks. Study visits will occur once a week for 4 weeks, and then every other week for the remainder of the 8 weeks. During these visits, many of the baseline questionnaires and interviews will be repeated. At the Week 8 visit, the physical exam, ECG, blood tests, and some baseline questionnaires will also be repeated. All children who respond well to atomoxetine may continue taking the drug for an additional 10 months. During this time, participants will report to the clinic once a month for the first 4 months, then once at the end of 7 months, and finally once at the end of 10 months. The same measures and procedures that were done during the 8-week phase will be done during the 10-month phase of this study.

Eligibility

Ages Eligible for Study:	6 Years to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis of an autism spectrum disorder (autistic disorder, Asperger's syndrome, and pervasive developmental disorder, not otherwise specified).
Significant hyperactivity, inattention, or impulsivity as determined by a score on an investigator-administered ADHD Rating Scale (ADHDRS)-Home Version that is at least 1.5 standard deviations above the mean for age and sex
Parent/caregiver's primary complaint about the child is inattention, hyperactivity, and/or impulsivity ("ADHD" symptoms)
Symptoms present for 6 months prior to study entry
Psychotropic drug-free for at least 2 weeks prior to starting study medication. This drug-free period will be 5 weeks for fluoxetine (Prozac).

Exclusion Criteria:

Weighs less than 15 kg (about 33 pounds)
Any another psychiatric disorder that may require a different treatment, including psychotic disorders, major affective disorders, obsessive-compulsive disorder, panic disorder, or substance-related disorders
DSM-IV diagnosis of Rett's disorder or childhood disintegrative disorder
Presence of extreme aggression or self-injury
Currently taking an effective psychotropic drug
Currently using other medications that may be unsafe to take with atomoxetine (e.g., potent CYP 2D6 inhibitors, intravenous albuterol, monoamine oxidase [MAO] inhibitors)
Inability to swallow study medication
Presence of a medical condition that would make treatment with atomoxetine unsafe (e.g., unstable hypertension or cardiac disease, asthma requiring frequent treatment with albuterol, narrow angle glaucoma, pregnancy, etc.)
Mental age of less than 18 months
Previous adequate trial of atomoxetine
Previous evidence of hypersensitivity or an allergic reaction to atomoxetine
Clinically significant abnormalities in laboratory measures indicating an undiagnosed medical condition as determined by the study physician in discussion with the participant's primary care physician
Clinically significant abnormalities on ECG as determined by a pediatric cardiologist
Pregnant
Initiation of a new psychosocial intervention within 90 days prior to starting study medication. Participants who have recently had a significant change in their psychosocial interventions will not be eligible until this intervention has been stable for 90 days in order to avoid confounding results of the study. Stable interventions (e.g., speech and occupational therapy) will be allowed to continue during the course of the study. Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation planned break in therapy due to school holidays) will not be considered significant.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00498173

Contacts

Contact: Jennifer Mullett, RN, CCRP	317-274-1981	mullettj@iupui.edu
Contact: Clinic email		kidpsych@iupui.edu

Locations

United States, Indiana
Christian Sarkine Autism Treatment Center at Riley Hospital for Children	Recruiting
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

David J. Posey, MD, MS

Indiana University School of Medicine

More Information

Click here for more information about the Indiana University School of Medicine Office of Clinical Research This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	Indiana University School of Medicine/Dept. of Child Psychiatry ( David J. Posey, MD, MS )
Study ID Numbers:	R01 MH77600, DDTR B2-NDA
Study First Received:	July 6, 2007
Last Updated:	September 30, 2008
ClinicalTrials.gov Identifier:	NCT00498173
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Autistic Disorder
Autism Spectrum Disorder

Study placed in the following topic categories:

Developmental Disabilities
Child Development Disorders, Pervasive
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Autistic Disorder

Mental Disorders Diagnosed in Childhood
Atomoxetine
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents

Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 30, 2009