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Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

Primary Purpose

Attention Deficit Hyperactivity Disorder, Dyslexia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Atomoxetine
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder

Eligibility Criteria

10 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD)
  • patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient
  • child or adolescent patients must be 10 to 16 years old
  • must be able to communicate in English
  • must be able to swallow capsules
  • be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

  • patients who weigh less than 25 Kg or greater than 70 Kg
  • patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months
  • patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder
  • females who are pregnant or breastfeeding
  • patients with a history of severe allergy to more than one class of medications
  • patients with documented history of bipolar I or bipolar II disorder, or psychosis

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Atomoxetine

Placebo

Arm Description

Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine

Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.

Outcomes

Primary Outcome Measures

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.

Secondary Outcome Measures

Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).

Full Information

First Posted
January 23, 2008
Last Updated
November 11, 2011
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00607919
Brief Title
Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia
Official Title
A Double-Blind Placebo Controlled Study of Atomoxetine Hydrochloride for the Treatment of ADHD in Children and Adolescents With ADHD and Comorbid Dyslexia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the effect of atomoxetine in treating Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms in children and adolescents with ADHD and comorbid reading disability (dyslexia)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder, Dyslexia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atomoxetine
Arm Type
Experimental
Arm Description
Atomoxetine will be administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo will be packaged in the same way as experimental drug to enforce double-blind study design. Placebo will be administered orally once daily in the morning. All eligible patients who complete the double-blind study period will have the option of participating in a 16-week open-label extension period in which patients will be treated with atomoxetine.
Intervention Type
Drug
Intervention Name(s)
Atomoxetine
Other Intervention Name(s)
LY139603
Intervention Description
Atomoxetine will be administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 to 32 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, daily, for 16 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
Description
Measures the 18 symptoms contained in the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnosis of Attention-Deficit/Hyperactivity Disorder (ADHD). Individual item scores range from 0 (none/never or rarely) to 3 (severe/very often). Total scores range from 0-54. Least Square mean of change from baseline in ADHDRS is from a restricted maximum likelihood-based, mixed model repeated measures analysis which includes the effects of treatment, investigative site, baseline, visit, treatment-by-visit interaction, and baseline-by-visit interaction.
Time Frame
Baseline, 16 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
Description
The ADHDRS-IV-Parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range 0-27, and inattention scores range 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
Description
The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3=severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
Description
The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
Description
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
Description
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
Description
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
Description
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
Description
LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
Description
The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
Description
The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).
Time Frame
Baseline, 16 weeks
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
Description
The ADHDRS-IV-parent is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
Description
The ADHDRS-IV-Teacher is an 18-item scale with 1 item for each of the 18 symptoms contained in the DSM-IV diagnosis of ADHD. Each item is scored on a 0 to 3 scale: 0=none (never or rarely); 1=mild (sometimes); 2=moderate (often); 3 =severe (very often). Hyperactivity-impulsivity scores range from 0-27, and inattention scores range from 0-27. Total scores range from 0-54. Higher scores indicate higher impairment.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
Description
The Woodcock Johnson Tests of Achievement has a Standard Battery (Tests 1-12) of a broad set of scores and an Extended Battery (Tests 13-22) on specific academic strengths and weaknesses. Tests associated with reading skills (1, 2, 7, 9, 13, 17, 20) were administered. Scores for each individual test can range from 0 to over 200 where anything 69 and below is very low and anything 131 and above is very superior. Higher scores indicate better reading skills.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
Description
The CTOPP assesses phonological awareness, phonological memory, and rapid naming and is appropriate for ages 7 to 24. The test contains six core subtests. The composite scores are 1) Phonological Awareness, comprised of the standard scores of the Elision and Blending Words; 2) Phonological Memory, comprised of standard scores for Memory for Digits and Non-word Repetition; and 3) Rapid Naming, comprised of standard scores for Rapid Digit Naming and Rapid Letter Naming. Standard scores range from 1-20, and composite scores range from 35-165. Higher scores are better.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
Description
The GORT-4 is a norm-referenced test of oral reading rate, accuracy, fluency, and comprehension valid for individuals aged 6 to 18 years old. The test has two parallel forms, Form A and Form B, that are administered in an alternating fashion (e.g. Week 0-Form A, Week 16-Form B, Week 32-Form A.) with each containing 14 separate stories and 5 multiple-choice comprehension questions for each story. GORT-4 yields the following scores: rate, accuracy, fluency, comprehension, and overall reading ability. Standard scores range from 1-20. Higher scores indicate better reading skills.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
Description
The TOWRE is a measure of an individual's ability to pronounce printed words accurately and fluently and is appropriate for individuals aged 6 to 24 years old. The TOWRE contains two subtests: Sight Word Efficiency (SWE) which assesses the number of real printed words that can be accurately identified within 45 seconds and Phonemic Decoding Efficiency (PDE) which measures the number of pronounceable printed non-words that can be accurately decoded within 45 seconds. Scores range from 45-146. Higher scores indicate higher reading proficiency.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
Description
WMTB-C is assessment of working memory capacities, consisting of 9 subtests (Trials Correct Scores [Range from 55-145], Higher scores are better) reflecting 3 main components of working memory: central executive (CE) control/regulation of working memory (Backward Digit Recall, Listening Recall, Counting Recall); phonological loop (PL) responsible for holding verbal information for short periods (Digit Recall, Word List Matching, Word List Recall, Non-word List Recall); and visuo-spatial sketchpad (VSSP) which holds information in visual and spatial form (Block Recall, Mazes Memory).
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
Description
LPS-C is a short (24 item, 0-3 points per item) parent-rated scale that is designed to assess changes in adaptive functioning related to treatment for ADHD. This scale measures improvements in social, emotional, cognitive, educational, and affiliative (family, friends) functioning, which indirectly reflect improvements in executive functioning. Happy/social subscores range from 0-18, and self-control subscores range from 0-54. Total scores range from 0-72. Higher scores are better for LPS.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
Description
The K-SCT rating scale contains 3 components: Youth, Parent, and Teacher ratings. It queries 17 candidate SCT symptoms, such as daydreams, lost in a fog, sluggish/drowsy. Scores range from 0-51. Lower scores indicate less sluggish.
Time Frame
Baseline, 32 weeks
Title
Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
Description
The MSCS is an overall assessment of self concept or an individual measure of any of the six scaled dimensions of self concept: Social, Competence, Affect, Academic, Family, and Physical. Standard scores range from 45-145. Higher scores are better (indicate higher self concept).
Time Frame
Baseline, 32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients must meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for Attention-Deficit/Hyperactivity Disorder (ADHD) patients must achieve a score of 80 or more on the Full Scale Intelligence Quotient child or adolescent patients must be 10 to 16 years old must be able to communicate in English must be able to swallow capsules be reliable to keep appointments for clinic visits and all related tests Exclusion Criteria: patients who weigh less than 25 Kg or greater than 70 Kg patients with a history of alcohol or drug abuse on a repeated basis within the past 3 months patients with documented history of autism, Asperger's syndrome or pervasive developmental disorder females who are pregnant or breastfeeding patients with a history of severe allergy to more than one class of medications patients with documented history of bipolar I or bipolar II disorder, or psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Irvine
State/Province
California
ZIP/Postal Code
92612
Country
United States
Facility Name
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.
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
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.
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
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.
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
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.
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
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.
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
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.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
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.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
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.
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27517
Country
United States
Facility Name
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.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45206
Country
United States
Facility Name
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.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
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.
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Facility Name
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.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
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.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
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.
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
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.
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27845858
Citation
McBurnett K, Clemow D, Williams D, Villodas M, Wietecha L, Barkley R. Atomoxetine-Related Change in Sluggish Cognitive Tempo Is Partially Independent of Change in Attention-Deficit/Hyperactivity Disorder Inattentive Symptoms. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):38-42. doi: 10.1089/cap.2016.0115. Epub 2016 Nov 15.
Results Reference
derived
PubMed Identifier
27410907
Citation
Shaywitz S, Shaywitz B, Wietecha L, Wigal S, McBurnett K, Williams D, Kronenberger WG, Hooper SR. Effect of Atomoxetine Treatment on Reading and Phonological Skills in Children with Dyslexia or Attention-Deficit/Hyperactivity Disorder and Comorbid Dyslexia in a Randomized, Placebo-Controlled Trial. J Child Adolesc Psychopharmacol. 2017 Feb;27(1):19-28. doi: 10.1089/cap.2015.0189. Epub 2016 Jul 13.
Results Reference
derived
PubMed Identifier
25019647
Citation
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.
Results Reference
derived
PubMed Identifier
24206099
Citation
Wietecha L, Williams D, Shaywitz S, Shaywitz B, Hooper SR, Wigal SB, Dunn D, McBurnett K. Atomoxetine improved attention in children and adolescents with attention-deficit/hyperactivity disorder and dyslexia in a 16 week, acute, randomized, double-blind trial. J Child Adolesc Psychopharmacol. 2013 Nov;23(9):605-13. doi: 10.1089/cap.2013.0054. Epub 2013 Nov 9.
Results Reference
derived

Learn more about this trial

Treatment of ADHD With Atomoxetine in Children & Adolescents With ADHD & Comorbid Dyslexia

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