Effects of Atomoxetine on Cognitive Function in Schizophrenia

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to examine the effects of atomoxetine (Strattera™) on prefrontal cognitive functioning in persons with schizophrenia. Secondarily, the effects of atomoxetine on positive and negative symptoms and on cigarette smoking consumption in persons with schizophrenia will be examined.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Alliance for Research on Schizophrenia and Depression
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Between ages 18 and 59;

• SCID-I for DSM-IV diagnosis of schizophrenia or schizoaffective disorder, and nicotine dependence

• Smoking at least 15 cigarettes per day, and have expired breath CO level >10 ppm,

• Be in stable remission from active psychiatric symptomatology, (as judged by trained clinical staff in the PRISM research program) and be on a stable dose of psychiatric medication(s) for the past 3 months

• No current abuse or dependence of alcohol or other substances of abuse within the past 3 months,

• Full scale IQ > 80,

• Presence of definable cognitive deficits of interest including VSWM, CPT, and WCST (e.g. at least one standard deviation below average).

• Able to give informed consent for participation.

Exclusion Criteria:

• Meet DSM-IV criteria for other major Axis I disorders besides those specified for each diagnostic group.

• Current abuse or dependence of alcohol or substances within the last 3 months, and subjects who are methadone maintained will be excluded.

• Full scale IQ < 80.

• Unable to give informed consent.

• Patients who are pregnant or planning on becoming pregnant will not be included in this study.

• Patients on paroxetine, fluoxetine, and quinidine will be excluded from this study.

• Are deemed medically unsafe to take atomoxetine, as judged by the study physician. Contraindications to the use of atomoxetine include hypersensitivity to atomoxetine, concurrent use of monoamine oxidase inhibitors (atomoxetine should be avoided during therapy with or within 2 weeks of discontinuing an MAO inhibitor), and patients with narrow angle glaucoma. Precautions would include concomitant administration with CYP 2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine) (which would necessitate a dose adjustment with atomoxetine), liver disease (enhanced risk of toxicity; empiric dose reduction is suggested based on clinical response; the drug should be avoided in acute hepatic failure), patients with hypertension, tachycardia, or other cardiovascular or cerebrovascular disease, patients with or at risk of hypotension , patients with urinary retention or bladder dysfunction.