The Effects of Atomoxetine on Cognition and Brain Function Based on Catechol-O-methyltransferase(COMT) Genotype
Condition: Schizophrenia; Memory Disorders; Cognition Disorders
MeSH terms: Memory Disorders; Schizophrenia; Cognition Disorders
Intervention: Atomoxetine; Functional magnetic resonance imaging; Neuropsychological Testing; Placebo
Intervention description: Comparison between Atomoxetine and Placebo; Comparison between Atomoxetine and Placebo arms; Comparison between Atomoxetine and Placebo arms; 25 mg, 40 mg, 60 mg and 80 mg Atomoxetine Placebo
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Genes; Dorsolateral Prefrontal Cortex; Dopamine; Functional Magnetic Resonance Imaging; Neuropsychological Testing; Schizophrenia; Atomoxetine; Cognitive Study; Pharmacogenetics; Normal Volunteers; Catechol-O-Methyltransferase; Healthy Volunteer

Summary:

      This study will evaluate whether Atomoxetine improves cognition in healthy volunteers as well
      as patients with schizophrenia. Atomoxetine is a drug that has been Food and Drug
      Administration (FDA) approved for Attention Deficit Disorder and allegedly increase the
      amount of the neurotransmitter dopamine in the frontal cortex of the brain.
    

Eligibility criteria:

        -  INCLUSION CRITERIA:

          -  Prior participation under NIH protocol # 95-M-0150, or new normal volunteers or
             schizophrenic patients that meet criteria for NIH protocol # 95-M-0150.

          -  No active Axis I or Axis II diagnosis in normal volunteers.

          -  Age range: 18-45 years.

          -  Normal EKG and blood pressure readings.

        EXCLUSION CRITERIA:

          -  Normal volunteers with an active Axis I or Axis II disorder or patients with an Axis I
             diagnosis other than schizophrenia or schizoaffective disorder obtained either from
             prior Structured Clinical Interview for the Diagnostic and Statistical Manual
             Disorders (SCID) interview in Protocol 95-M-0150 or through a screening interview will
             be excluded.

          -  Subjects with a history of cardiovascular disease, liver disease and other serious
             medical illnesses, and untreated or uncontrolled hypertension will be excluded because
             of the potential for drug-drug interaction or because of the potential deleterious
             effect of the drug on the medical condition. An electrocardiogram, blood pressure,
             pulse rate, toxicological screen, cell blood count and metabolic panel including Liver
             Function Tests (LFTs) will be checked on all subjects prior to participation in the
             study. Any subject with an electrocardiogram deemed abnormal by a cardiologist or with
             sustained systolic blood pressure of 150 mmHg or above, diastolic blood pressure of
             100 mmHg or above will be excluded from the study.

          -  Schizophrenic patients taking a COMT inhibitor, any illicit drugs of abuse, or
             Monoamine Oxidase (MAO) inhibitors will be excluded. Patients taking paroxetine,
             fluoxetine, bupropion, tricyclic antidepressants, albuterol, modafinil, stimulants or
             pressor agents will be excluded from the study. No medication will be stopped in order
             to participate in the study.

          -  Normal control subjects taking any medication other than occasional nonsteroidal
             anti-inflammatory drugs (NSAID) or with recent history of illicit drug or alcohol
             abuse will be excluded. Normal controls on contraceptive medication will be excluded
             from the study.

          -  Pregnant women: Women of childbearing potential will undergo a urine pregnancy test
             the day the study initiates and they will be screened by history for the possibility
             of pregnancy.