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

Phase 4

Completed

• Conditions: ADHD

• Registration Number: NCT00190736
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2006-09
• Status Verified: 2007-11
• Last Update Submitted: 2007-11-05
• Last Update Posted: 2007-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Atomoxetine administered QD in the AM, provides superior efficacy in the evenings compared with placebo in ADHD adults.

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 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.; 🇺🇸 Middleton, Wisconsin, United States