Strattera Treatment in Adults With Attention Deficit Hyperactivity Disorder Not Otherwise Specified (ADHD NOS)
Condition: ADHD NOS
MeSH terms: Attention Deficit Disorder with Hyperactivity
Intervention: Strattera (atomoxetine)
Intervention description: Up to maximum of 1.2mg atomoxetine/kg PO QD, or 120 mg atomoxetine PO QD (whichever is less).
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: ADHD NOS; Adults; Strattera (atomoxetine); Open-Label

Summary:

      This is an open-label study with daily doses up to 144 mg/day Strattera (atomoxetine) in the
      treatment of adults with attention deficit hyperactivity disorder not otherwise specified.
      The researchers hypothesize ADHD symptomatology in adults with ADHD NOS will be responsive to
      Strattera treatment and Strattera treatment (in doses of up to 120 mg/day or 1.5 mg/kg/day,
      whichever is less) in adults with ADHD NOS will be safe and well tolerated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and female outpatients older than 18 and younger than 55 years of age.

          2. Subjects with the diagnosis of attention deficit hyperactivity disorder not otherwise
             specified (ADHD NOS), by Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition (DSM-IV), as manifested in clinical evaluation and confirmed by structured
             interview. This is operationalized by either:

               1. having currently at least 6/9 current items of either inattention or
                  hyperactivity/impulsivity but < 5 items from either list in childhood; or

               2. having 5 out of 9 current DSM-IV items of inattention and/or
                  hyperactivity/impulsivity, but not having 6 current symptoms in either category.
                  This second category will be included independent of the presence or absence of
                  ADHD symptoms in childhood.

          3. Subjects will have a current Clinical Global Impression ADHD score of 4 or higher.

          4. Subjects with past history of depression or anxiety disorder (including obsessive
             compulsive disorder [OCD]) without current disorder for > 3 months as ascertained
             through structured diagnostic interview and clinical exam will be allowed to
             participate.

          5. Subjects treated for anxiety disorders and depression who are on a stable medication
             regimen for at least three months, and who have a disorder specific CGI-severity score
             ≤ 3 (mildly ill) and who have a score on the Hamilton-depression and Hamilton-anxiety
             rating scale below 15 (mild range) will be included in the study.

          6. Subjects with past history of substance use disorders but have been asymptomatic for
             at least 6 months and have a negative drug screen will be allowed to participate.

          7. Subjects receiving non-monoamine oxidase inhibitor (MAOI) antidepressants (e.g.,
             selective serotonin reuptake inhibitors [SSRIs], bupropion, venlafaxine), or
             benzodiazepines who have been on a stable regimen for > 3 months for any of the
             conditions listed above.

          8. Subjects with mild cases of asthma and allergy will be allowed to participate.

          9. Subjects with acid reflux syndrome will be allowed to participate.

         10. Subjects with hypercholesterolemia who are on a stable dose of cholesterol-lowering
             medication will be allowed to participate.

        Exclusion Criteria:

          1. Any clinically unstable psychiatric conditions including the following: acute
             psychosis, acute panic, acute OCD, acute mania, acute suicidality, lifetime history of
             bipolar disorder, acute substance use disorders (alcohol or drugs), sociopathy,
             criminality.

          2. Any metabolic, neurological, hepatic, renal, cardiovascular, hematological,
             ophthalmic, or endocrine disease.

          3. Clinically significant abnormal baseline laboratory values which include the
             following:

               1. Values larger than 20% above the upper range of the laboratory standard of a
                  basic metabolic screen.

               2. Exclusionary blood pressure parameters will include any values above 140
                  (systolic) and 90 (diastolic).

               3. Exclusionary electrocardiogram (ECG) parameters will include a QTC > 460 msec,
                  QRS > 120 msec, and PR > 200 msec. Subjects having ECG evidence of ischemia or
                  arrhythmia as reviewed by an independent cardiologist.

          4. Mental retardation (intelligence quotient [I.Q.] < 75).

          5. Organic brain disorders.

          6. Pregnant or nursing females.

          7. Subjects with current adequate treatment for ADHD or a history of a previous adequate
             trial of Strattera.

          8. Subjects who have failed to respond to an adequate trial, or who have had tolerability
             problems on Strattera.

          9. Only English-speaking subjects will be allowed into the study for the following
             reasons:

               1. the assessment instruments are not available and have not been adequately
                  standardized in other languages;

               2. the researchers' clinical trials facility is located in Cambridge and not in the
                  Massachusetts General Hospital (MGH) main campus without the availability of
                  translators;

               3. psychiatric questionnaires and evaluations are taxing and adding the complexity
                  of a translator has the potential to make the patient experience even more
                  exhausting.

         10. Prior hypersensitivity to Strattera.

         11. MAOI antidepressant use currently or within two weeks of starting study.

         12. Urinary retention or bladder dysfunction.