Official Title: “An Open-Label Study of the Efficacy of Atomoxetine Hydrochloride on Quality of Life of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder With or Without Comorbid Conditions”

This study aims to assess the effectiveness of atomoxetine on psychosocial functioning and emotional well being of children and adolescents with ADHD and to evaluate whether and in what measure the presence of comorbid conditions (internalizing and externalizing disorders) influences atomoxetine's ability to improve the quality of life of ADHD subjects.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: October 2008

Intervention(s) in this Clinical Trial

• Drug: atomoxetine
  • 0.5 mg/kg/day, PO for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Attention Deficit Hyperactivity alone
• Experimental: B
  • Attention Deficit Hyperactivity Disorder plus internalizing disorders
• Experimental: C
  • Attention Deficit Hyperactivity Disorder plus externalizing disorders

Primary Measures

• Child Health and Illness Profile - Child Edition (CHIP-CE), achievement domains
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• 18-items ADHD subscale Swanson, Nolan and Pelham Rating scale (SNAP-IV)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Clinical Global Impressions-ADHD-Severity (CGIS-ADHD-S)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• CHIP-CE (satisfaction, comfort, resilience and risk avoidance domains and subdomains)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Pediatric Anxiety Rating Scale (PARS)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Children's Depression Rating Scale-Revised (CDRS-R)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• SNAP-IV Oppositional Scale
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Child Symptom Inventory-4: Parent Checklist (CSI-4) or Adolescent Symptom Inventory-4: Parent Checklist (ASI-4), parent evaluation of ADHD subscale
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Child Symptom Inventory-4: Parent Checklist (CSI-4) or Adolescent Symptom Inventory-4: Parent Checklist (ASI-4), parent evaluation of comorbidity symptoms
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Conners' Teacher Rating scale-Revised: Short Form (CTRS-R:S)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Adverse Events (AEs)
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Child or adolescent patients, male or female outpatients, who are at least 6 years of age, but must not yet have reached their 16th birthday prior to Visit 1, when informed consent is obtained
• Patients must meet DSM-IV diagnostic criteria for ADHD (any subtype) and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the SNAP-IV ADHD Subscale score at both Visit 1 and 2
• Laboratory results, including serum chemistries, hematology, and urinalysis, must show no clinically significant abnormalities (clinically significant 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)
• An ECG must be performed to exclude cardiac diseases at the baseline/screening visit and the results must be reviewed by the investigator at Visit 2 prior to dispensing of study material
• Patients and parents have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests, including venipuncture, and examinations required by the protocol.

Exclusion Criteria:

• Patients who have a documented history of Bipolar I or II disorder, any history of psychosis or pervasive development disorder
• Patients with a history of any seizure disorder (other than febrile seizures) or patients who have taken (or are currently taking) anticonvulsants for seizure control are not eligible to participate
• Patients at serious suicidal risk as assessed by the investigator
• Patients with significant cardiovascular disease or other conditions that could be aggravated by an increased heart rate or increased blood pressure
• Patients who have any medical condition that would increase sympathetic nervous system activity markedly (for example, catecholamine-secreting neural tumor), or who are taking a medication on a daily basis (for example, albuterol, inhalation aerosols, pseudoephedrine), that has sympathomimetic activity. Such medications can be taken on an as-needed basis

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 15 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00320528

Study ID Number: 9867

ClinicalTrials.gov Identifier: NCT00320528

Health Authority: Italy: Ministry of Health

Lilly Clinical Trial Registry