- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00486122
Evaluation of Continuous Symptom Treatment of ADHD
June 11, 2007 updated by: Eli Lilly and Company
Evaluation of Continuous Symptom Treatment of ADHD: A Placebo-Controlled Double-Blind Assessment of Morning-Dosed or Evening-Dosed Strattera
The purpose of this study is to test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
282
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Columbus, Ohio, United States
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must have ADHD that meets disease diagnostic criteria as defined by DSM-IV-Revised
- Males or females who are at least 6 years old and no more than 12 years old prior to visit 2
- Patients must be able to swallow capsules
- Patients must be of normal intelligence in the judgment of the investigator. Normal intelligence is defined as being without evidence of significant general intellectual deficit and expected to achieve a score of 70 or more if formal IQ testing were administered.
- Laboratory results must show no significant abnormalities (significance is defined as laboratory values requiring acute medical intervention, indicating a serious medical illness, or requiring further medical evaluation in the judgment of the investigator)
Exclusion Criteria:
- Patients who weigh less than 20 kg or greater than 65 kg at study entry (visit 1)
- Patients who have a documented history of bipolar I or bipolar II disorder, or psychosis
- Patients who have documented autism, Asperger's syndrome, or pervasive developmental disorder.
- Other comorbid psychiatric disorders are not excluded provided that the diagnosis of ADHD predates the comorbid disorder, and that the ADHD symptoms are the primary source of impairment for the patient
- Patients taking any antipsychotic medication during the 4 weeks prior to visit 1 are not eligible.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Test the hypothesis that atomoxetine administered orally, once a day, at doses up to 1.4 mg/kg/day for approximately 6 weeks given in the morning is superior to placebo in children with ADHD
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Secondary Outcome Measures
Outcome Measure |
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Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy compared with placebo in children with ADHD
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Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the evenings compared with placebo in children with ADHD
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Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD based on the CGIP-M
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To assess the effect of dosing atomoxetine in the morning versus placebo on measures of executive functioning
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Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy compared with placebo for measures of adaptive functioning in children with ADHD
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Test the hypothesis that atomoxetine administered once daily in the evening provides superior efficacy in the evenings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
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Test the hypothesis that atomoxetine administered once daily in the morning provides superior efficacy in the mornings (before daily dosing, i.e., nearly 24 hrs since last dosing) compared with placebo in children with ADHD
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To examine the onset of action during the first week of treatment in the morning versus in the evening versus placebo
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To assess the effect of dosing atomoxetine in the evening versus placebo on measures of executive functioning
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To compare morning versus evening dosing versus placebo as assessed by the CGI-ADHD-S
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To assess the safety and tolerability of atomoxetine dosed in the morning versus in the evening versus placebo
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bangs ME, Wietecha LA, Wang S, Buchanan AS, Kelsey DK. Meta-analysis of suicide-related behavior or ideation in child, adolescent, and adult patients treated with atomoxetine. J Child Adolesc Psychopharmacol. 2014 Oct;24(8):426-34. doi: 10.1089/cap.2014.0005. Epub 2014 Jul 14.
- Newcorn JH, Sutton VK, Zhang S, Wilens T, Kratochvil C, Emslie GJ, D'souza DN, Schuh LM, Allen AJ. Characteristics of placebo responders in pediatric clinical trials of attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2009 Dec;48(12):1165-72. doi: 10.1097/CHI.0b013e3181bc730d.
- Block SL, Kelsey D, Coury D, Lewis D, Quintana H, Sutton V, Schuh K, Allen AJ, Sumner C. Once-daily atomoxetine for treating pediatric attention-deficit/hyperactivity disorder: comparison of morning and evening dosing. Clin Pediatr (Phila). 2009 Sep;48(7):723-33. doi: 10.1177/0009922809335321. Epub 2009 May 6.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2003
Study Completion (ACTUAL)
June 1, 2004
Study Registration Dates
First Submitted
June 11, 2007
First Submitted That Met QC Criteria
June 11, 2007
First Posted (ESTIMATE)
June 13, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
June 13, 2007
Last Update Submitted That Met QC Criteria
June 11, 2007
Last Verified
June 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Attention Deficit and Disruptive Behavior Disorders
- Neurodevelopmental Disorders
- Attention Deficit Disorder with Hyperactivity
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- 7972
- B4Z-US-LYCC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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