Trials / Completed
CompletedNCT00488163
Pilot Study of Atomoxetine To Enhance COgnition In Patients With Schizophrenia
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Research Foundation for Mental Hygiene, Inc. · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Atomoxetine | Dose escalation from 40 mg to 50 mg of Atomoxetine active treatment. |
Timeline
- Start date
- 2005-01-01
- Primary completion
- 2007-04-01
- Completion
- 2007-06-01
- First posted
- 2007-06-20
- Last updated
- 2017-10-05
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00488163. Inclusion in this directory is not an endorsement.