Clinical trial NCT00607919: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Dyslexia
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-02-06
Enrollment: 209
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
Secondary outcomes:
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
measure: Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
timeFrame: Baseline, 32 weeks
Other outcomes:
Locations:
city: Irvine
country: United States
facility: 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.
state: California
city: Palo Alto
country: United States
facility: 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.
state: California
city: San Francisco
country: United States
facility: 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.
state: California
city: New Haven
country: United States
facility: 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.
state: Connecticut
city: Tampa
country: United States
facility: 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.
state: Florida
city: Libertyville
country: United States
facility: 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.
state: Illinois
city: Indianapolis
country: United States
facility: 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.
state: Indiana
city: Lexington
country: United States
facility: 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.
state: Kentucky
city: Chapel Hill
country: United States
facility: 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.
state: North Carolina
city: Cincinnati
country: United States
facility: 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.
state: Ohio
city: Columbus
country: United States
facility: 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.
state: Ohio
city: Oklahoma City
country: United States
facility: 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.
state: Oklahoma
city: Pittsburgh
country: United States
facility: 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.
state: Pennsylvania
city: San Antonio
country: United States
facility: 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.
state: Texas
city: Burlington
country: United States
facility: 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.
state: Vermont
city: Spokane
country: United States
facility: 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.
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.