Phase 4
N=445
Treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) With Atomoxetine in Young Adults and Its Effects on Functional Outcomes
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00510276 ↗Enrolled (actual)
445
Serious AEs
0.4%
Results posted
Mar 2010
Primary outcome: Primary: 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 — -14.88; -9.82 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine hydrochloride (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-14.88; -9.82 | <0.001 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Total Score |
15.76; 10.95 | 0.005 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Quality of Life-29 (AAQOL-29) Relationship Subscale |
15.51; 9.61 | 0.006 sig |
| SECONDARY 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 |
20.92; 15.18 | 0.018 sig |
| SECONDARY 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 |
14.57; 10.21 | 0.034 sig |
| SECONDARY 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 |
9.27; 5.87 | 0.074 |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint in Clinical Global Impression-ADHD- Severity (CGI-ADHD-S) |
-1.10; -0.67 | <0.001 sig |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint in CAARS Self Report (CAARS-S:SV) Total Score |
-11.88; -7.84 | <0.001 sig |
| SECONDARY Endpoint Scores in Patient Global Impression - Improvement (PGI-I) |
3.17; 3.42 | 0.020 sig |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Montgomery Asberg Depression Rating Scale (MADRS) |
-0.72; -0.30 | 0.282 |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Beck Anxiety Inventory (BAI) |
-2.58; -2.07 | 0.556 |
| SECONDARY 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 |
-0.591 | <0.001 sig |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Alcohol |
-0.21; -0.06 | 0.198 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Caffeine |
-0.23; -0.20 | 0.825 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Drugs |
0.02; 0.02 | — |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Nicotine |
0.01; -0.81 | 0.233 |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Habits Timeline Followback (TLFB) Incidence for Use of Marijuana |
0.09; 0.03 | 0.676 |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Fagerstrom Test for Nicotine Dependence (FTND) |
0.12; 0.43 | 0.382 |
| SECONDARY Mean Change From Baseline to 12 Week Endpoint on the Social Adaptation Self-Evaluation Scale (SASS) |
1.24; 1.46 | 0.656 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey Self-Report |
1.93; 3.54 | 0.201 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Driving Behavior Survey-Other Report |
3.24; 2.63 | 0.933 |
| SECONDARY 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 |
-8.15; -5.20 | 0.007 sig |
| SECONDARY 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 |
-1.98; -1.40 | 0.219 |
| SECONDARY 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 |
-22.41; -14.83 | 0.002 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inconsistency Section |
-0.51; -0.42 | 0.644 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Infrequency Section |
0.27; 0.16 | 0.097 |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Inhibit Section |
-2.62; -1.65 | 0.002 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Initiate Section |
-2.41; -1.74 | 0.044 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Metacognition Section |
-14.13; -9.64 | 0.003 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - Negativity Section |
-0.85; -0.71 | 0.456 |
| SECONDARY 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 |
-2.50; -1.85 | 0.051 |
| SECONDARY 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 |
-3.62; -2.28 | 0.002 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Behavior Rating Inventory of Executive Function-Adult Version Self Report (BRIEF-A) - SHIFT Section |
-1.49; -0.96 | 0.045 sig |
| SECONDARY 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 |
-2.03; -1.20 | 0.001 sig |
| SECONDARY 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 |
-2.28; -1.57 | 0.008 sig |
| SECONDARY 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 |
-3.48; -2.18 | <0.001 sig |
| SECONDARY Mean Change From Baseline to 12-Week Endpoint on the Epworth Sleepiness Scale (ESS) |
-1.76; -1.07 | 0.065 |
| SECONDARY Responders by Baseline Smoking Status |
54; 60; 29; 53 | 0.788 |
| SECONDARY Strong Responders by Baseline Smoking Status |
38; 41; 19; 31 | 0.482 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00510276). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.