Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes

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 attention-deficit/hyperactivity disorder (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.

Intervention(s) in this Clinical Trial

• Drug: Atomoxetine hydrochloride
  • 20-50 mg, twice a day per by mouth for 12 weeks, followed by up to an additional 12 weeks
• Drug: Placebo
  • twice a day, by mouth for 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Atomoxetine
• Placebo Comparator: Placebo

Primary Measures

• Mean Change in the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom Score From Baseline to 12 Week Endpoint
  • Time Frame: Baseline, Week 12
    Safety Issue?: No

Secondary Measures

• Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Productivity Subscale
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Psychological Health Subscale
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Life Outlook Subscale
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Endpoint Scores in Patient Global Impression - Improvement (PGI-I)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Correlation of Mean Changes From Baseline to 12 Week on the Adult ADHD Quality of Life-29 Total Score and of Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating Scale-Investigator Rated:Screening Version Total Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Behavioral Regulation Section Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Emotional Control Section Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - GEC Section Score
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Organization of Materials Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Plan/Organize Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Self Monitor Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Task Monitor Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Working Memory Section
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS)
  • Time Frame: Baseline, 12 weeks
    Safety Issue?: No
• Responders by Baseline Smoking Status
  • Time Frame: 12 weeks
    Safety Issue?: No
• Strong Responders by Baseline Smoking Status
  • Time Frame: 12 weeks
    Safety Issue?: No

Inclusion Criteria:

• positive attention-deficit/hyperactivity disorder (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 Investigator: Eli Lilly and Company Industry

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 February 09, 2012

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