An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).

Official Title: “An Italian Randomised, Double-blind Placebo Controlled Study of the Efficacy of Atomoxetine Hydrochloride in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder”

The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD). The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and ODD symptoms in patients non responders to a previous psychological intervention with parent support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid conditions associated with ADHD and ODD will be assessed.

Intervention(s) in this Clinical Trial

• Drug: atomoxetine 0.5 mg/kg/day
  • atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
• Drug: placebo
• Drug: atomoxetine 1.2 mg/kg/day
  • atomoxetine 1.2 mg/kg/day QD, PO
• Drug: atomoxetine 1.2-1.4 mg/kg/day
  • atomoxetine 1.2 - 1.4 mg/kg/day QD, PO

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine
  • atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.
• Placebo Comparator: Placebo
  • placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine receives marketing approval.

Primary Measures

• Change From Baseline to 8 Week Endpoint in Swanson, Nolan and Pelham Questionnaire (SNAP-IV): Attention-Deficit/Hyperactivity Disorder (ADHD) Subscale
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No

Secondary Measures

• Change From Baseline to 8 Week Endpoint in Clinical Global Impressions - Attention-Deficit/Hyperactivity Disorder (ADHD) - Severity
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Screen for Child Anxiety Related Emotional Disorders (SCARED) Total Score
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Conners' Parent Rating Scale-Revised: Short Form Subscale Scores
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Child Health and Illness Profile - Child Edition (CHIP-CE): Parent Rated Form
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No
• Change From Baseline to 8 Week Endpoint in Conners' Teacher Rating Scale-Revised: Short Form Subscale Scores
  • Time Frame: Visit 8 (baseline) and Visit 14 (8 weeks)
    Safety Issue?: No

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 Diagnostic and Statistical Manual of Mental Disorders Fourth
• Edition (DSM-IV) diagnostic criteria for ADHD (any subtype) and ODD and score at least 1.5 standard deviations above the age norm for their diagnostic subtype using published norms for the Swanson, Nolan and Pelham Questionnaire:
• Attention-Deficit/Hyperactivity Disorder (SNAP-IV ADHD) Subscale score at both Visit 1 and 2.
• They must also have a SNAP-IV ODD subscale score of at least 15 at both Visit 1 and Visit 2.
• Other comorbid conditions, are allowed but the diagnosis of ADHD and ODD must be the patient's primary diagnosis.
• Patients must be of normal intelligence in the judgment of the investigator (that is, without a general impairment of intelligence and likely, in the investigator's judgement, to achieve a score of greater than or equal to 70 on an Intelligence
• Quotient (IQ) test). The administration of a formal IQ test is not an entry requirement for the study. Specific learning disabilities are not considered general impairment of intelligence.

Exclusion Criteria:

• Patients who weigh less than 20 kilograms (kg) at study entry (Visit 1).
• 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 who, in the investigator's judgment, are likely to need psychotropic medications apart from the drug under the study, including health-food supplements that the investigator feels have central nervous system activity (for example, St.
• John's Wort, melatonin).

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 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  

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00192023

Study ID Number: 8856

ClinicalTrials.gov Identifier: NCT00192023

Health Authority: Italy: Ministry of Health

Lilly Clinical Trial Registry