Official Title: “A Double-Blind Study of Atomoxetine Hydrochloride Versus Placebo for the Treatment of ADHD in Young Adults With an Assessment of Associated Functional Outcomes”

This study will evaluate atomoxetine's efficacy in treating ADHD symptoms and atomoxetine's effect on functional outcomes in young adults.

A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

This study also has an observational community sample arm in which patients will complete all the efficacy measurements via web-based self reporting.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2009

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine hydrochloride
  • 40-100 mg/day BID, PO for 12 weeks then up to an additional 12 weeks
• Drug: Placebo
  • BID, PO, 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Placebo Comparator: 2

Primary Measures

• Conners' Adult ADHD Rating Scale- Investigator Rated: Screening Version (CAARS-Inv:SV)
  • Time Frame: 12 weeks
    Safety Issue?: No

Secondary Measures

• Adult ADHD Quality of Life -29 (AAQOL-29)
  • Time Frame: 12 weeks
    Safety Issue?: No
• AAQOL-29 relationship subscale
  • Time Frame: 12 weeks
    Safety Issue?: No
• AAQOL-29 Life Productivity subscale
  • Time Frame: 12 weeks
    Safety Issue?: No
• AAQOL-29 Psychological Health subscale
  • Time Frame: 12 weeks
    Safety Issue?: No
• AAQOL-29 Life Outlook subscale
  • Time Frame: 12 weeks
    Safety Issue?: No
• Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
  • Time Frame: 12 weeks
    Safety Issue?: No
• CAARS Self Report (CAARS-S:SV)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Patient Global Impression - Improvement (PGI-I)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Montgomery Asberg Depression Rating Scale (MADRS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Beck Anxiety Inventory (BAI)
  • Time Frame: 12 weeks
    Safety Issue?: No
• AAQOL-29 total score correlated to CAARS-Inv: SV total score
  • Time Frame: 12 weeks
    Safety Issue?: No
• Habits Timeline Followback (TLFB) incidents for use of alcohol, nicotine, caffeine, marijuana, and drugs
  • Time Frame: 12 weeks
    Safety Issue?: No
• Fagerstrom Test for Nicotine Dependence
  • Time Frame: 12 weeks
    Safety Issue?: No
• Social Adaptation Self-Evaluation Scale (SASS)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Driving Behavior Survey Self-Report
  • Time Frame: 12 weeks
    Safety Issue?: No
• Driving Behavior Survey-Other Report
  • Time Frame: 12 weeks
    Safety Issue?: No
• Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A)
  • Time Frame: 12 weeks
    Safety Issue?: No
• Epworth Sleepiness Scale
  • Time Frame: 12 weeks
    Safety Issue?: No
• Baseline smoking status as a predictor of response
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• positive ADHD diagnosis with at least moderate severity
• male or female 18 to 30 years of age
• must be able to swallow capsules
• must be able to communicate effectively in English
• must not have cognitive impairment
• be reliable to keep appointments for clinic visits and all related tests

Exclusion Criteria:

• patients diagnosed with obsessive-compulsive disorder, bipolar affective disorder, or psychosis
• females who are pregnant or breastfeeding
• patients with dementia or traumatic brain injury
• patients with a history of severe allergy to atomoxetine
• have untreated hypertension or thyroid problem
• have serious medical illness including any heart, liver, kidney, respiratory, blood, endocrine, or neuromuscular diseases

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 30 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and 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) Study Director Eli Lilly and Company  

Overall Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00510276

Study ID Number: 10803

ClinicalTrials.gov Identifier: NCT00510276

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry