Phase 4
N=502
A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00190775 ↗Enrolled (actual)
502
Serious AEs
1.4%
Results posted
Oct 2010
Primary outcome: Primary: Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score — -16.43; -8.65 Units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Atomoxetine Hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 24 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score |
-16.43; -8.65 | <0.001 sig |
| PRIMARY Change From Baseline to 12 Weeks in the Conners' Adult Attention Deficit Hyperactivity Disorder Rating Scale - Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptoms Score |
-14.33; -10.05 | 0.001 sig |
| SECONDARY Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant |
-0.79; -0.41; -0.25; -0.04; -0.63; -0.29 | 0.905 |
| SECONDARY Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant |
-0.81; -0.90; -0.33; 0.27; -1.15; -0.58 | 0.176 |
| SECONDARY Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other |
-0.28; 0.15; -0.86; -0.35; -0.15; -0.05 | 0.575 |
| SECONDARY Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other |
-0.79; 0.24; -0.93; -0.41; 0.14; -0.09 | 0.941 |
| SECONDARY Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant |
1.13; 0.70; 1.61; 1.42; 0.52; -0.02 | 0.617 |
| SECONDARY Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Participant |
1.21; 0.51; 2.13; 1.58; 0.47; -0.32 | 0.544 |
| SECONDARY Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other |
2.09; 2.64; 2.49; 3.67; 1.37; 1.61 | 0.334 |
| SECONDARY Change From Baseline to 24 Weeks in the Dyadic Adjustment Scale (DAS) - Spouse/Significant Other |
2.09; 2.84; 2.79; 3.87; 1.32; 1.27 | 0.248 |
| SECONDARY Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress |
-10.74; -7.06; 0.25; -0.30 | 0.446 |
| SECONDARY Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains |
-5.08; -1.34; -1.78; -1.24; -0.68; -0.11 | 0.056 |
| SECONDARY Change From Baseline to 8 Weeks in the Parenting Stress Index (PSI) Score - Child Domains |
-5.66; -5.72; -1.66; -0.35; -1.70; -1.93 | 0.578 |
| SECONDARY Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Total Stress and Life Stress |
-17.19; -10.97; 0.99; 0.19 | 0.280 |
| SECONDARY Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Parent Domains |
-7.66; -3.12; -2.58; -1.57; -1.08; -0.28 | 0.103 |
| SECONDARY Change From Baseline to 24 Weeks in the Parenting Stress Index (PSI) Score - Child Domains |
-9.52; -7.85; -2.28; -0.84; -2.28; -2.60 | 0.785 |
| SECONDARY Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form |
0.27; 0.67; 0.00; 0.36; -1.29; -1.17 | 0.420 |
| SECONDARY Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Parent Form |
0.31; 0.43; 0.07; 0.11; -1.24; -0.96 | 0.784 |
| SECONDARY Change From Baseline to 12 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form |
0.08; -0.17; 0.38; -0.15; -0.80; -0.24 | 0.895 |
| SECONDARY Change From Baseline to 24 Weeks in the Alabama Parenting Questionnaire (APQ) Child Form |
0.12; -0.11; 0.36; 0.44; -0.90; -0.33 | 0.828 |
| SECONDARY Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form |
-2.93; -2.57; -1.18; -1.26; -1.75; -1.30 | 0.583 |
| SECONDARY Mean Change From Baseline to 24 Weeks in the Child Disruptive Behavior Rating Scale (CDBRS) Parent Form Oppositional Defiant Disorder (ODD) and Conduct Disorder Flags |
54; 40; 127; 119; 40; 33 | .792 |
| SECONDARY Change From Baseline to 8 Weeks in the Parenting Sense of Competence (PSOC) Scale |
3.51; 2.52; 1.77; 1.26; 1.75; 1.25 | 0.875 |
| SECONDARY Change From Baseline to 24 Weeks in the Parenting Sense of Competence (PSOC) Scale |
4.57; 2.93; 2.48; 1.53; 2.09; 1.41 | 0.365 |
| SECONDARY Change From Baseline to 12 and 24 Weeks in the Adult Attention Deficit Hyperactivity Disorder Investigator Symptom Rating Scale Total and Subscale Scores |
-13.26; -9.06; -5.84; -4.37; -7.42; -4.66 | 0.001 sig |
| SECONDARY Change From Baseline to 8 and 24 Weeks in the Clinical Global Improvement Attention Deficit Hyperactivity Disorder Severity (CGI-ADHD-S) |
-1.13; -0.69; -1.18; -0.67 | <0.001 sig |
| SECONDARY Change From Baseline to 12 and 24 Weeks in the Montgomery-Asberg Depression Rating Scale Total Score (MADRS) |
-0.69; 0.14; -0.61; 0.36 | 0.553 |
| SECONDARY Change From Baseline to 12 and 24 Weeks in the State-Trait Anxiety Inventories (STAI) |
-1.50; 1.12; -5.67; -2.42; -0.40; 0.38 | 0.108 |
| SECONDARY Change From Baseline to 1 Week of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores |
-7.92; -7.62; -5.12; -3.21; -3.51; -2.41 | 0.892 |
| SECONDARY Change From Baseline to 2 Weeks of Titration in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores |
-10.55; -10.58; -7.77; -4.61; -4.76; -3.43 | 0.722 |
| SECONDARY Change From Baseline to After a 2-Week Titration Period Beginning at Week 24 and Ending at Week 26 in the CAARS-Inv:SV Total Attention Deficit Hyperactivity Disorder (ADHD) Symptoms and Subscale Scores: Dosing Titration Strategy After Placebo |
-4.54; -4.92; -0.17; -1.71; -2.00; -0.06 | 0.546 |
Summary
This is a parallel design, double-blind, placebo-controlled, multi-center, 38-week treatment trial of atomoxetine in adults with attention deficit hyperactivity disorder (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 12 and 24 weeks of blinded treatment.
Eligibility Criteria
Inclusion Criteria
- Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition - Text Revision (DSM-IV-TR) criteria for Adult Attention-Deficit/Hyperactivity Disorder (ADHD) as assessed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID).
- Have a Clinical Global Impression for ADHD Severity Score (CGI-ADHD-S) 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 and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for any history of bipolar disorder or any history of a psychotic 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.
Data sourced from ClinicalTrials.gov (NCT00190775). 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.