Official Title: “A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder: With a Secondary Examination of Impact of Treatment on Family Functioning”

This is a parallel design, double-blind, placebo-controlled, multi-center, 34-week treatment trial of atomoxetine in adults with ADHD who are currently living in a family situation with at least one child. The primary objective of the study is to demonstrate the efficacy of atomoxetine compared to placebo in the reduction of ADHD symptoms over 24 weeks of blinded treatment.

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: December 2009

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine Hydrochloride
• Drug: placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • atomoxetine 40 mg/day x 3 days followed by 80 mg/day for 11 days OR 40 mg/day x 7 days followed by 80 mg/day for 7 days then 60/80/100 mg investigator determined to 24 weeks, PO
• Placebo Comparator: B
  • placebo is administered QD, PO for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day, PO

Primary Measures

• Conners' Adult ADHD Rating Scale - Investigator Rated: Screening Version.
  • Time Frame: over 24 weeks
    Safety Issue?: No

Secondary Measures

• Dyadic Relationship Scale of the Family Assessment Measure Version III (FAM III)
  • Time Frame: 8 weeks, 24 weeks
    Safety Issue?: No
• Dyadic Adjustment Scale (DAS)
  • Time Frame: 8 weeks, 24 weeks
    Safety Issue?: No
• Parenting Stress Inventory (PSI)
  • Time Frame: 8 weeks, 24 weeks
    Safety Issue?: No
• Alabama Parenting Questionnaire Parent form and Child form
  • Time Frame: 12 weeks, 24 weeks
    Safety Issue?: No
• Disruptive Behavior Rating Scale
  • Time Frame: 24 weeks
    Safety Issue?: No
• Parenting Sense of Competence Scale
  • Time Frame: 8 weeks, 24 weeks
    Safety Issue?: No
• Initial dosing strategy assessment
  • Time Frame: 1 week and 2 weeks
    Safety Issue?: No
• Dosing Titration strategy after placebo
  • Time Frame: after two week titration period
    Safety Issue?: No

Inclusion Criteria:

• Meet DSM-IV-TR criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the CAADID
• Have a Clinical Global Impression for ADHD Severity Score of 4 or greater Visit 2 and 3
• Adult Men and Women age 18 years or older at time informed consent is obtained.
• Must be in a reciprocal relationship with a person of the opposite sex living in same defined household (cohabitating)with their spouse/significant other for a period of at least 3 months. This spouse/significant other cannot change during the study.
• Must have one or more children 6-17 years of age living the home as the primary residence

Exclusion Criteria:

• Anyone meeting diagnostic (DSM-IV) criteria for bipolar disorder
• Anyone meeting diagnostic (DSM-IV) criteria for current major depression or current anxiety disorder
• Taking psychotropic medications on a regular basis
• Having any medical condition that would be exacerbated or not appropriate for inclusion in this trial.
• Previously taken an adequate trial of atomoxetine

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

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  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00190775

Study ID Number: 9043

ClinicalTrials.gov Identifier: NCT00190775

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry