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Tracking Information | |||||||||||||
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First Received Date † | June 13, 2008 | ||||||||||||
Last Updated Date | March 9, 2009 | ||||||||||||
Start Date † | August 2008 | ||||||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † |
Effectiveness of atomoxetine versus placebo in treating children with autism or PDDNOS who exhibit symptoms of ADHD [ Time Frame: Measured at Week 10 and Week 24 of extension phase ] [ Designated as safety issue: Yes ] | ||||||||||||
Change History | Complete list of historical versions of study NCT00699205 on ClinicalTrials.gov Archive Site | ||||||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
Effectiveness of atomoxetine plus parent management versus atomoxetine alone in treating children who exhibit symptoms of ADHD [ Time Frame: Measured at Week 10 and Week 24 of extension phase ] [ Designated as safety issue: Yes ] | ||||||||||||
Descriptive Information | |||||||||||||
Brief Title † | Atomoxetine and Parent Management Training in Treating Children With Autism and Symptoms of Attention Deficit Disorder With Hyperactivity | ||||||||||||
Official Title † | Atomoxetine, Placebo, and Parent Training in Autism | ||||||||||||
Brief Summary | This study will evaluate the effectiveness of the medication atomoxetine, with and without parent management training, in treating children with autism or pervasive developmental disorder not otherwise specified who have symptoms of attention deficit hyperactivity disorder. |
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Detailed Description | Autism and pervasive developmental disorder not otherwise specified (PDDNOS), an autism spectrum disorder, are brain development disorders characterized by abnormalities in communication, social interactions, and range of interests. Overactivity and inattention, both symptoms of attention deficit hyperactivity disorder (ADHD), are commonly reported among children with autism. Recent data have suggested that at least 14% of children with autism are treated for ADHD symptoms, typically with stimulant medication. However, response rates to stimulant medication are poorer among children with autism than among typically developing children with ADHD, suggesting a substantial need for potential alternative treatment options. Previous studies have shown that training programs that teach parents ways to address adaptive behavior and behavioral problems can be effective in improving symptoms of autism and ADHD in children. Parent training, in combination with the nonstimulant ADHD medication atomoxetine, may be the best way to improve emotional and attention-related problems in children with autism and ADHD. This study will evaluate the effectiveness of the medication atomoxetine, with and without parent management training (PMT), in treating children with autism or PDDNOS who have symptoms of ADHD. Participation in this study will last 9 months and will include two phases. Phase 1 will last 12 weeks. After screening, all eligible child participants will undergo baseline assessments that will include tests of attention and/or memory on a computer system, vital sign measurements, and a review of past medications. Parent participants will also complete questionnaires about their child's behavior and symptoms and a review of any previous parent training experiences. Participants will then be assigned randomly to one of four treatment groups: atomoxetine plus PMT, atomoxetine alone, placebo plus PMT, or placebo alone. Child participants will take their assigned study medication twice daily for 10 weeks and will attend weekly clinic visits. During these visits, child participants will undergo vital sign measurements, possible medication adjustments, and some of the baseline learning testing. Parent participants will be asked questions about their child's side effects and behavior. Participants assigned to also receive PMT will individually meet with a clinician weekly for 10 weeks. The sessions involving a parent and child or parent alone will include parenting instruction, practice activities, behavior rehearsal with feedback from the behavior therapist, and role-playing of specific skills. Parents will also be given at-home homework assignments that will involve practicing techniques learned in sessions and collecting information on their child's behavior. At the end of Phase 1, all participants will repeat the baseline assessments and children will undergo a physical exam. Any child participants who have shown improvement after Phase 1 will be invited to participate in Phase 2, which will last 24 weeks. Child participants will continue to take their assigned medications from Phase 1 and, if applicable, will continue PMT sessions once a month. They will attend 6 monthly clinic visits that will involve the same procedures conducted in Phase 1 visits. Upon completing the 24 additional weeks of treatment, all participants will undergo repeat baseline assessments. |
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Study Phase | Phase IV | ||||||||||||
Study Type † | Interventional | ||||||||||||
Study Design † | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety/Efficacy Study | ||||||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||||||
Recruitment Status † | Recruiting | ||||||||||||
Estimated Enrollment † | 156 | ||||||||||||
Estimated Completion Date | April 2013 | ||||||||||||
Estimated Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||||||
Ages | 5 Years to 14 Years | ||||||||||||
Accepts Healthy Volunteers | No | ||||||||||||
Contacts †† | |||||||||||||
Location Countries † | United States | ||||||||||||
Expanded Access Status | |||||||||||||
Administrative Information | |||||||||||||
NCT ID † | NCT00699205 | ||||||||||||
Responsible Party | Tristram Smith, MD, Site PI, University of Rochester | ||||||||||||
Secondary IDs †† | DDTR B2-NDA | ||||||||||||
Study Sponsor † | National Institute of Mental Health (NIMH) | ||||||||||||
Collaborators †† | |||||||||||||
Investigators † |
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Information Provided By | National Institute of Mental Health (NIMH) | ||||||||||||
Verification Date | March 2009 | ||||||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |