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View Clinical Trial (Medical Research Study)
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A Dose-Response Study of Modafinil Effects on Cognition in Healthy Adults and in Schizophrenia Patients - NCT00711464-95817 (Clinical Trial 230288)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy230288.aspx
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| City: |
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Sacramento |
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State:
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CA |
| Zip Code: |
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95817 |
| Conditions: |
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Schizophrenia |
| Purpose: |
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Patients with schizophrenia have problems in thinking, known as cognitive dysfunction. This
includes many types of cognitive dysfunction, such as in attention, memory and language.
These problems may explain why patients with schizophrenia think and act in unusual ways,
and often have problems managing aspects of their lives that healthy adults take for
granted. Unfortunately, the biochemical aspects of these dysfunctions are presently unknown,
and it is not clear whether current psychiatric medications can improve these functions. A
recent FDA-approved medication that may improve this function is modafinil. Studies in
animals and healthy adults show that this medication can improve many of these cognitive
functions. We plan to study the effects of modafinil on these cognitive processes, by giving
various doses of this medication to patients before they perform tasks of these cognitive
processes. We will also enroll healthy adults in these same procedures in order to determine
how these effects are manifest in normal-range cognitive function. We predict that when
patients or control participants receive modafinil, they will perform better on cognitive
tests, and that these benefits will depend on the dose given.
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| Study summary: |
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Schizophrenia is a disorder of cognition. The cognitive deficits of schizophrenia are
present at the onset of the disorder, prior to medication exposure, are persistent during
periods of remission, and are strongly related to functional outcome. These deficits
prominently include prefrontal cortex-dependent functions. While existing medications
effectively treat psychotic symptoms, they exhibit modest benefit at best for cognitive
dysfunction. Studies of cognition in animal models indicate that the neurotransmitter
systems that mediate many cognitive processes are not generally augmented by existing
antipsychotic medications. Therefore, advances in the treatment of schizophrenia will
require the study of agents with novel pharmacological profiles to establish their potential
to remediate cognitive dysfunction.
This study will evaluate the effects of modafinil on the range of cognitive processes known
to be disturbed in schizophrenia. Modafinil is an FDA-approved medication with a unique
pharmacological profile and an increasing range of off-label indications. Its neurochemical
effects in animal models include elevation of extracellular dopamine (DA), noradrenaline
(NA) and glutamate in the neocortex. This profile is favorable for the enhancement of
cognitive processes. These neurochemical effects also appear to be selective for cortical
versus subcortical brain regions, suggesting that modafinil may have minimal effects on
psychotic symptoms, or extrapyramidal, autonomic and hormonal side effects. In addition, it
differs from amphetamine in structure, neurochemical profile and behavioral effects, with a
lower risk of addictive or cerebrovascular effects. Recent studies in animal models, healthy
adults and adults with psychiatric and neurological disorders indicate that modafinil
improves prefrontal cognitive functions. This suggests that modafinil is a leading candidate
for the treatment of cognitive dysfunction in schizophrenia. We aim to test modafinil
effects on these processes in healthy adults, in order to evaluate modafinil effects on
normal-range cognition, and then evaluate the remediation of deficits in these functions in
individuals with schizophrenia. We will vary the dose within each participant to evaluate
dose-response relationships, and directly compare cognition outcome measures for sensitivity
to drug effects. |
| Criteria: |
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Inclusion Criteria:
- adults age 18-54
- diagnosis of schizophrenia or schizoaffective disorder, or healthy with no personal
or family history of mental illness
- able to provide informed consent
Exclusion Criteria:
- history of significant head injury or other neurological illness
- active psychiatric illness requiring significant acute care
- significant intellectual impairment (e.g. standardized full-scale IQ < 70)
- history of medical illness or treatment that is associated with significant increase
in risk from modafinil treatment (e.g. cardiac disease)
- significant active substance abuse
- active pregnancy
- active treatment with medications that have drug interactions with modafinil |
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| Study is available at: |
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University of California, Davis School of Medicine
Sacramento, CA 95817
United States
Primary Contact:
Michael J Minzenberg, MD
Email: michael.minzenberg@ucdmc.ucdavis.edu
Phone: 916-734-7174 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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