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Sponsors and Collaborators: |
Research Foundation for Mental Hygiene Eli Lilly and Company |
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Information provided by: | Research Foundation for Mental Hygiene |
ClinicalTrials.gov Identifier: | NCT00488163 |
Relationships between altered prefrontal cortical dopamine, norepinephrine and some cognitive impairments of schizophrenia supports and approach for pharmacological remediation of cognitive symptoms through manipulations of prefrontal cortical dopamine and norepinephrine. Atomoxetine, a selective norepinephrine re-uptake inhibitor, produces a widespread increase in brain norepinephrine and a secondary and selective increase in prefrontal dopamine. Given this, we are evaluating atomoxetine’s cognitive effects in a pilot placebo controlled trial in patients with schizophrenia. Moreover, an fMRI investigation was undertaken to assess the neural mechanisms underlying the cognitive effects of atomoxetine.
Condition | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Atomoxetine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia |
Enrollment: | 20 |
Study Start Date: | January 2005 |
Study Completion Date: | June 2007 |
Participants carrying a diagnosis of schizophrenia and receiving treatment with one of the following antipsychotic medications are eleigible for participation: risperidone, olanzapine, quetiapine, aripirazole. Following consent, participants will be observed for 4 weeks to ensure stability of their symptoms. Following this, there will be baseline assessments of symptom severity, cognitive ability, functional ability and an fMRI scan. Following this, participants will be randomly assigned to receive treatment with 40 mg of atomoxetine or placebo daily during a double-blind parallel designed four week treatment period, following which the dose of atomoxetine will be increased to 40 mg twice day (or matching placebo) for an additional 4 weeks. The cognitive assessment battery and MRI will be repeated following 8 weeks of treatment.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, New York | |
Pilgrim Psychiatric Center | |
W. Brentwood, New York, United States, 11717 | |
Mount Sinai Hospital | |
New York, New York, United States, 10029 |
Principal Investigator: | Joseph I Friedman, MD | Pilgrim Psychiatric Center |
Study ID Numbers: | 00131-03-1284 |
Study First Received: | June 18, 2007 |
Last Updated: | June 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00488163 |
Health Authority: | United States: Institutional Review Board |
schizophrenia cognition atomoxetine norepinephrine dopamine |
Schizophrenia Dopamine Mental Disorders Norepinephrine |
Atomoxetine Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents |
Adrenergic Uptake Inhibitors Physiological Effects of Drugs Pharmacologic Actions |