Atomoxetine to Treat Asian Adult Patients With Attention-Deficit/Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Intervention: Atomoxetine; Placebo
Intervention description: 40-120 milligrams (mg) taken by mouth, once daily for 10 weeks.; Taken by mouth, once daily for 10 weeks.
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 391.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ADHD

Summary:

      The purpose of this study is to assess the efficacy, the quality of life, and the safety of
      multiple dosing atomoxetine in Asian adult subjects with attention deficit/hyperactivity
      disorder (ADHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) criteria for current attention
             deficit/hyperactivity disorder (ADHD) as well as criteria for a historical diagnosis
             of ADHD during childhood, both assessed by the Conners' Adult
             Attention-Deficit/Hyperactivity Disorder Diagnostic Interview for Diagnostic and
             Statistical Manual of Mental Disorders, Fourth Edition at screening

          -  Patients must have a score of 2 or greater on at least 6 items of either the
             inattentive or hyperactive/impulsive core subscales at randomization or screening on
             the rated Conners' Adult Attention-Deficit/Hyperactivity Disorder Rating
             Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) 18-item total ADHD symptom
             score. In addition, their total score on the 18-item total ADHD symptom score must be
             20 or greater.

          -  Patients must have a Clinical Global Impressions-Attention-Deficit/Hyperactivity
             Disorder-Severity score of 4 (moderate symptoms) or greater.

          -  Patients must have been judged by the investigator to be reliable to keep appointments
             for clinic visits and all tests, required by the protocol.

          -  Patients must possess an educational level and degree of understanding of the language
             of their country that enables them to communicate suitably with the investigator and
             study coordinator.

          -  Patients must be able to swallow capsules.

        Exclusion Criteria:

          -  Patients who meet full DSM-IV-TR diagnostic criteria for any history of bipolar
             disorder or any history of schizophrenia and other psychotic disorders, or patients
             who had received injectable sustained-release neuroleptics.

          -  Patients with depressive disorder who also have a total score of 12 or greater on the
             Hamilton Depression Rating Scale-17 items at randomization. Patients who have both a
             current or past history of major depression and received any anti-depression drug
             therapy within 6 months of screening.

          -  Patients who meet DSM-IV-TR diagnostic criteria for current anxiety disorder and also
             patients who require anti-anxiety drug therapy, except for those taking benzodiazepine
             analogs for anxiety, which need to be limited.

          -  Patients who have been diagnosed (DSM-IV-TR) with a pervasive developmental disorder.

          -  Patients who, in the opinion of the investigator, are at serious suicidal risk or
             serious risk of harming others, or whose score for Item 11 on the Hamilton Depression
             Rating Scale-17 items is equal or more than 2 at randomization or screening.

          -  Patients who have received atomoxetine in a prior clinical study.

          -  Patients with significant medical conditions that are likely to become unstable during
             the trial or would likely be destabilized by treatment with atomoxetine.

          -  Patients with a history of allergy to atomoxetine, severe allergies to more than 1
             class of medications, or multiple adverse drug reactions.

          -  Patients who have received treatment within the past 30 days with a drug that has not
             received regulatory approval for any indication at the time the informed consent
             document is obtained.