Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

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Brief Title

Comparison of Atomoxetine Versus Placebo in Children and Adolescents With ADHD and Comorbid ODD in Germany

Official Title

A Randomized, Double-Blind Comparison of Atomoxetine Versus Placebo in Children and Adolescents With Attention-Deficit/Hyperactivity Disorder and Comorbid Oppositional Defiant Disorder

Brief Summary

      A three-arm, randomized, double-blind, placebo-controlled, Phase 4, multicenter study to
      compare the efficacy and safety of atomoxetine versus placebo in children and adolescents
      aged 6 through 17 years with attention-deficit/hyperactivity disorder (ADHD) and comorbid
      oppositional defiant disorder (ODD) who are treated as outpatients in Germany. After an
      initial 3- to 28-day screening and washout phase, participants will be assigned to
      double-blind treatment with atomoxetine or placebo. A 2 week up-titration period will be
      succeeded by a 7 week treatment period at the target dose. The primary efficacy measure will
      be the Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) ODD subscale score.
    


Study Phase

Phase 4

Study Type

Interventional


Primary Outcome

Swanson, Nolan and Pelham Rating Scale Revised (SNAP-IV) Oppositional Defiant Disorder: (ODD) Score

Secondary Outcome

 Swanson, Nolan & Pelham Rating Scale - Revised (SNAP-IV): ADHD Combined Score

Condition

Attention Deficit Hyperactivity Disorder

Intervention

Atomoxetine

Study Arms / Comparison Groups

 Atomoxetine Fast Titration
Description:  0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

181

Start Date

November 2006

Completion Date

January 2009

Primary Completion Date

January 2009

Eligibility Criteria

        Inclusion Criteria:

          -  Male or female outpatients who are at least 6 years of age, and who will not have
             reached their 18th birthday

          -  Diagnosis of ADHD and presence of Diagnostic and Statistical Manual of Mental
             Disorders, Fourth Edition (DSM-IV) criteria A through C for ODD (NOTE: diagnosis for
             conduct disorder not exclusionary)

          -  Normal intelligence

          -  Able to swallow capsules

        Exclusion Criteria:

          -  Weigh less than 20 kilogram (kg) or more than 90 kg at study entry

          -  Prior treatment with atomoxetine

          -  History of seizure disorder, suicidal risk, alcohol or drug abuse within the past 3
             months

          -  History of severe allergies or multiple adverse drug reactions

          -  Cardiovascular disorders: hypertension, unexplained cardiac signs or symptoms, QT
             (measure of the time between the start of the Q wave and the end of the T wave in the
             heart's electrical cycle) prolongation , inherited cardiac disorders
      

Gender

All

Ages

6 Years - 17 Years

Accepts Healthy Volunteers

No

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), , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00406354

Organization ID

11149

Secondary IDs

B4Z-SB-LYDW


Study Sponsor

Eli Lilly and Company


Study Sponsor

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


Verification Date

February 2010