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

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Lilly

Status and phase

Completed
Phase 4

Conditions

Attention Deficit Hyperactivity Disorder
Oppositional Defiant Disorder

Treatments

Drug: Atomoxetine
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00406354
B4Z-SB-LYDW (Other Identifier)
11149 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

181 patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

181 participants in 3 patient groups, including a placebo group

Atomoxetine Fast Titration
Experimental group
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
Treatment:
Drug: Atomoxetine
Atomoxetine Slow Titration
Experimental group
Description:
0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
Treatment:
Drug: Atomoxetine
Placebo
Placebo Comparator group
Description:
matching placebo daily dose taken orally
Treatment:
Drug: Placebo

Trial contacts and locations

6

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Data sourced from clinicaltrials.gov

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