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

Verified by: Eli Lilly and Company, November 2011
First Received: January 23, 2008 | Last Updated: November 11, 2011 | Phase: Phase 4 | Start Date: March 2008
Overall Status: Completed | Estimated Enrollment: 209
  • …
  • Tell a FriendPrint

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...

Brief Summary

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”

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)

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: November 2010

Intervention(s) in this Clinical Trial

  • Drug: Atomoxetine
    • 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
  • Drug: Placebo
    • oral, daily, for 16 weeks

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Atomoxetine
    • 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 Comparator: Placebo
    • 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.

Outcome Measures for this Clinical Trial

Primary Measures

  • Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total Score - Parent Version at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No

Secondary Measures

  • Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Woodcock-Johnson III Scores at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 16 Endpoint
    • Time Frame: Baseline, 16 weeks
      Safety Issue?: No
  • Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Parent Version at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHDRS) Total and Subscores - Teacher Version at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Woodcock-Johnson III Scores at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Comprehensive Test of Phonological Processing (CTOPP) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Gray Oral Reading Test-4 (GORT-4) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Test of Word Reading Efficiency (TOWRE) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Working Memory Test Battery for Children (WMTB-C) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Life Participation Scale-child (LPS-C) Score at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Kiddie Sluggish Cognitive Tempo (K-SCT) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No
  • Change From Baseline in Multidimensional Self Concept Scale (MSCS) at Week 32 Endpoint
    • Time Frame: Baseline, 32 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 10 Years

Maximum Age for this Clinical Trial: 16 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Eli Lilly and Company Industry

Overall Clinical Trial Officials and Contacts

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) Study Director Eli Lilly and Company  

Additional Information

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00607919

Study ID Number: 11672

ClinicalTrials.gov Identifier: NCT00607919

Health Authority: United States: Food and Drug Administration

(Lilly Clinical Trial Registry)

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00607919