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Completed

NCT Number: NCT00192023

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).

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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., Alessandria, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

atomoxetine 0.5 mg/kg/day

Drug

atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO)

Other names: LY139603, Strattera

Placebo

Drug

atomoxetine 1.2 mg/kg/day

Drug

atomoxetine 1.2 mg/kg/day QD, PO

Other names: LY139603, Strattera

atomoxetine 1.2-1.4 mg/kg/day

Drug

atomoxetine 1.2 - 1.4 mg/kg/day QD, PO

Other names: LY139603, Strattera

Primary outcomes

  1. 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)

    Items from the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for ADHD are included for the two subsets of symptoms: inattention (items #1-#9) and hyperactivity/impulsivity (items #11-#19). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 54.

Secondary outcomes

  1. 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)

    Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients.

  2. Change From Baseline to 8 Week Endpoint in SNAP-IV Oppositional Subscale

    Time frame: Visit 8 (baseline) and Visit 14 (8 weeks)

    Items are included from the DSM-IV criteria for Oppositional Defiant Disorder (items #21-#28). The SNAP-IV is based on a 0 (not at all) to 3 (very much) rating scale. Total subscale scores range from 0 to 24.

  3. 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)

    The scale measures symptoms of DSM-IV linked anxiety disorders in children. Contains 41 items. Individual item scores range from 0 (not true or hardly ever true) to 2 (very true or often true). Therefore, the overall score ranges from 0 to 82. Higher scores are more indicative of greater anxiety.

  4. Change From Baseline to 8 Week Endpoint in Children's Depression Rating Scale-Revised

    Time frame: Visit 8 (baseline) and Visit 14 (8 weeks)

    Measures presence and severity of depression. Consists of 17 items scored on a 1-5 or 1-7 scale. A rating of 1 indicates normal, thus the minimum score is 17. The maximum score is 113. In general, scores below 20 indicate an absence of depression; scores of 20 or 30 indicate borderline depression; scores of 40 to 60 indicate moderate depression.

  5. 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)

    A 27-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the parent to assess problem behaviors related to ADHD. Subscales: Oppositional, Cognitive Problems, Hyperactivity, and ADHD Index. Subscale total scores range from 0 to 18 for all subscales except ADHD Index which ranges from 0 to 36.

  6. 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)

    Parent-rated assessment of a child's health status and level of functioning. It consists of 76 items. The majority of items assess frequency of activities or feelings using a five-point response format (for example, 'how good is your child at making friends?' 1=never, 5=always). Standard scores (t-value) were established, with all domains and subdomains having a mean score of 50 and standard deviation of 10. Standard scores are expressed in standard deviation units. T-score=[(score-4.2382)*10/0.32835] + 50. Higher scores mean improvement.

  7. 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)

    A 28-item rating scale (0 [not at all/never] to 3 [very much true/very often]) completed by the teacher to assess problem behaviors related to ADHD. Subscale total scores range from 0 to 15 for Oppositional and Cognitive Problems, 0 to 21 for Hyperactivity, and 0 to 36 for ADHD Index.

Other outcomes

  1. Open-Label Phase Serious Adverse Events

    Time frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval

    Number of participants with serious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.

  2. Open-Label Phase Nonserious Adverse Events

    Time frame: Baseline (Visit 14) though 1.5 years (Visit 20) or until atomoxetine received marketing approval

    Number of participants with nonserious adverse events during the open-label phase of the trial, which was for 1.5 years or until atomoxetine received marketing approval.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2008
First posted
Sep 19, 2005
Registry last updated
Jan 18, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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