A Randomized, Double-Blind Comparison of Placebo and Atomoxetine Hydrochloride Given Once a Day in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine Hydrochloride; Placebo
Intervention description: 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; 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.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 502.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.