Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)

A Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Comparison of Fixed-Dose Ranges of Atomoxetine Hydrochloride in Child Outpatients With Attention-Deficit/Hyperactivity Disorder

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191295

Enrollment

240

Registered

2005-09-19

Start date

2005-02-28

Completion date

2006-09-30

Last updated

2007-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Hyperactivity Disorder

Brief summary

Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

DRUGAtomoxetine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

Inclusion criteria

* Patients are diagnosed with ADHD * Patients must be able to swallow capsules * Patients must be of normal intelligence

Exclusion criteria

* Patients who weigh less than 15 kg or more than 75 kg * Patients with organic brain disease (for example, dementia or traumatic brain injury residual)

Design outcomes

Primary

Measure	Time frame
Change of total score on ADHD RS-IV-JParent Version: Investigation-Administered and Scored	—

Secondary

Measure	Time frame
Relationship between atomoxetine doses and both efficacy and safety variables	—
Plasma concentration of atomoxetine and its metabolites	—
Changes on ADHD RS-IV-J-School Version score	—

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026