Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (2)

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
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Baseline, 24 weeks
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
30-item scale containing 3 subscales: inattention (9 items), hyperactivity/ impulsivity (9 items), and ADHD Index (12 items). Each item is scored 0-3 (0=not at all/never; 1=just a little/once in a while; 2=pretty much/often; 3=very much/very frequently). Total ADHD symptoms score=sum of the inattention and hyperactivity/impulsivity subscales. Total Scores range from 0-54 (range of 0-27 for the inattention and hyperactivity subscales; 0-36 for the ADHD Index) with higher scores indicating more impaired participants. The scale was administered by a physician/PhD at the investigative site.
Baseline, 12 weeks

Secondary Outcomes (29)

Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
Baseline, 8 weeks
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Participant
Baseline, 24 weeks
Change From Baseline to 8 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
Baseline, 8 weeks
Change From Baseline to 24 Weeks in the Family Assessment Measure Version III (FAM) Dyadic Relationship Scale (DRS) - Spouse/Significant Other
Baseline, 24 weeks
Change From Baseline to 8 Weeks in the Dyadic Adjustment Scale (DAS) - Participant
Baseline, 8 weeks
+24 more secondary outcomes

Study Arms (2)

Atomoxetine

EXPERIMENTAL

Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally

Drug: Atomoxetine Hydrochloride

Placebo

PLACEBO COMPARATOR

Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Drug: Placebo

Interventions

Atomoxetine HydrochlorideDRUG

Atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 60/80/100 mg as determined by the investigator up to 24 weeks, orally

Also known as: LY139603, Strattera

Atomoxetine

PlaceboDRUG

Placebo is administered QD, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
Previously taken an adequate trial of atomoxetine.

Contact the study team to confirm eligibility.