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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00441649 |
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Date of registration:
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28/02/2007 |
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Primary sponsor: |
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Public title:
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Methylphenidate for Treating Children With ADHD and Tourette Syndrome
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Scientific title:
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Methylphenidate Treatment of ADHD in Children With Tourette Syndrome |
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Date of first enrolment:
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February 2000 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00441649 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Contacts
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Name:
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Kenneth D. Gadow, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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State University of New York at Stony Brook |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Diagnosis of ADHD or ADHD plus Tourette syndrome
Exclusion Criteria:
- Determined to be dangerous to self or others
- Scores less than 70 on an IQ test
- Any seizure disorder, major organic brain dysfunction, major medical illness, major
mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory
loss
- Any condition that may make use of methylphenidate unsafe
Age minimum:
6 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Attention Deficit Disorder With Hyperactivity
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Tourette Syndrome
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Intervention(s)
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Drug: Methylphenidate
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Primary Outcome(s)
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ADHD symptoms
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Adverse drug reactions (all measured at 2-week intervals throughout the study)
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Anxiety and mood symptoms
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Frequency and severity of tics and obsessive compulsive disorder symptoms
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Oppositional and aggressive behavior
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Rebound tic exacerbation
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Tic impairment, tic severity, and clinical response
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Secondary ID(s)
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DDTR B2-NDH
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R01 MH45358
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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