Atomoxetine
DrugDose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
Other names: Strattera®
NCT Number: 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.
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Notify Me18 year–65 year
All sexes
Interventional
Phase 4
Pilgrim Psychiatric Center, Brentwood, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment.
Other names: Strattera®
Time frame: 8 weeks
Cognitive performance as measured by the BACS
Time frame: 8 weeks
Differences between changes in brain oxygenation level dependent imaging measures between placebo and Atomoxetine
Research Foundation for Mental Hygiene, Inc.
Other
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