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Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months)

Efficacy and Safety of Once-Daily Atomoxetine Hydrochloride in Adults With ADHD Over an Extended Period of Time (6 Months); With a Brief Evaluation of Executive Cognition

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00190736
Enrollment
440
Registered
2005-09-19
Start date
2004-09-30
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

ADHD

Brief summary

A study to compare the effect of once-daily atomoxetine versus placebo in treating symptoms of ADHD in adults for up to 6 months.

Interventions

DRUGAtomoxetine Hydrochloride
DRUGplacebo

Sponsors

Eli Lilly and Company
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 54 Years
Healthy volunteers
No

Inclusion criteria

* Male and Female patients with ADHD ages 18-54. * Patient must have ADHD symptoms that cause problem(s) in the home setting.

Exclusion criteria

* Have failed to respond to an adequate trial of treatment with an ADHD stimulant medication, bupropion, or other nonstimulant medication. * Are taking any antipsychotic medication or mood stabilizers within 8 weeks of Visit 1

Design outcomes

Primary

MeasureTime frame
Atomoxetine administered orally, QD in the AM, from 25 mg/day to 100 mg/day for 6 months is superior to placebo in ADHD adults.—

Secondary

MeasureTime frame
Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults.—

Countries

United States

Outcome results

None listed

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