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Completed

NCT Number: NCT00191698

Comparison of Atomoxetine and Placebo in Children and Adolescents With ADHD and ODD

The purpose of this trial is to test the effectiveness of atomoxetine in treating symptoms of ODD in children with ADHD and ODD.

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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–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, call 1-877-CTLILLY (1-877-285-4559) or 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., Wallsend, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients are male or female outpatients who are at least 6 years of age and not more than 12 years of age at study entry.
  • Patients must meet DSM-IV diagnostic criteria for ADHD and ODD.
  • If other comorbid conditions are present, either the ADHD or the ODD diagnosis must be the patient's primary diagnosis.
  • Patients must have laboratory results, including serum chemistries, hematology, and urinalysis showing no significant abnormalities.
  • Patients must have an ECG performed at study entry that is absent of any abnormality that, in the opinion of the physician, should exclude the patient.

Exclusion criteria

  • Patients who weigh less than 20 kg or greater than 60 kg at study entry.
  • Patients who have a history of Bipolar I or II disorder, psychosis, or pervasive developmental disorder.
  • Patients who have a current diagnosis of Major Depressive Disorder ([MDD]; with or without psychotic features), PTSD, or CDRS-R total raw score >40 at study entry.
  • Patients with a history of any seizure disorder.
  • Patients determined by the investigator to be at serious suicidal risk.

Treatment and study plan

Atomoxetine Hydrochloride

Drug

Other names: LY139603, Strattera

Placebo

Drug

Primary outcomes

  1. Mean reduction in ODD symptoms using the Swanson, Nolan and Pelham Rating Scale-Revised (SNAP-IV), atomoxetine vs placebo

    Time frame: over 8 weeks

Secondary outcomes

  1. Mean change in the investigator-rated SNAP-IV ADHD subscales, atomoxetine vs placebo

    Time frame: over 8 weeks

  2. Mean change in ratings on the Oppositional subscale of the SNAP-IV

    Time frame: over 8 weeks

  3. Mean change in ADHD symptoms by ADHD subscales of the SNAP-IV, 2.4 mg/kg/day vs 1.2 mg/kg/day.

    Time frame: over 4 weeks

  4. Mean change in ratings on the Clinical Global Impressions-Severity (CGI-S).

    Time frame: over 8 weeks

  5. Psychosocial functioning as measured by the total score on the Attention Deficit Hyperactivity Disorder Impact Module (AIM).

    Time frame: over 8 weeks

  6. Environmental stress exacerbation of ODD symptoms by Social Readjustment Rating Scale (SRRS).

    Time frame: 8 weeks, 12 weeks

  7. Adverse events (AEs)

    Time frame: over 1 year

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind Comparison of Atomoxetine Hydrochloride and Placebo in Child and Adolescent Outpatients With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Important dates

Study start
2003
Primary completion
2005
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
Oct 31, 2008

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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