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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).

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00192023
First received: September 12, 2005
Last updated: December 9, 2009
Last verified: December 2009

September 12, 2005
December 9, 2009
October 2004
August 2006   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
to test the hypothesis that atomoxetine is superior to placebo in improving ADHD symptomatology after 8 weeks of double-blind treatment on fixed dosage of atomoxetine in pediatric outpatients with ADHD and ODD.
Complete list of historical versions of study NCT00192023 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as 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) ] [ Designated as safety issue: No ]
  • to test the hypothesis that atomoxetine is superior to placebo in reducing symptoms of ODD, in improving mood of children and adolescents with ADHD as measured by the anxiety/depression scales, in ameliorate problem behaviors related to ADHD.
  • Will be evaluated if atomoxetine has a superior effect in comparison to placebo on the emotional and social well-being of the child and the family and whether parent support induces a different response on ADHD symptoms in respect to ODD symptoms.
  • Will be assessed the long-term efficacy, tolerability and safety of atomoxetine during an extension phase of the protocol
Not Provided
Not Provided
 
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).
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Attention Deficit Hyperactivity Disorder
  • Oppositional Defiant Disorder
  • Drug: atomoxetine 0.5 mg/kg/day
    atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)
    Other Names:
    • LY139603
    • Strattera
  • Drug: placebo
  • Drug: atomoxetine 1.2 mg/kg/day
    atomoxetine 1.2 mg/kg/day QD, PO
    Other Names:
    • LY139603
    • Strattera
  • Drug: atomoxetine 1.2-1.4 mg/kg/day
    atomoxetine 1.2 - 1.4 mg/kg/day QD, PO
    Other Names:
    • LY139603
    • Strattera
  • 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.
    Interventions:
    • Drug: atomoxetine 0.5 mg/kg/day
    • Drug: atomoxetine 1.2 mg/kg/day
    • Drug: atomoxetine 1.2-1.4 mg/kg/day
  • 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.
    Interventions:
    • Drug: atomoxetine 0.5 mg/kg/day
    • Drug: placebo
    • Drug: atomoxetine 1.2-1.4 mg/kg/day
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
139
May 2008
August 2006   (final data collection date for primary outcome measure)

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).
Both
6 Years to 15 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00192023
8856, B4Z-IT-LYCY
No
Chielf Medical Officer, Eli Lilly
Eli Lilly and Company
Not Provided
Study Director: 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 ) Eli Lilly and Company
Eli Lilly and Company
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP