Modafinil Effects on Cognition in Schizophrenia Patients
| Status: | Completed |
|---|---|
| Conditions: | Schizophrenia |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 54 |
| Updated: | 10/1/2017 |
| Start Date: | May 2008 |
| End Date: | July 2012 |
A Dose-response Study of Modafinil Effects on Cognition in Schizophrenia Patients.
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
predict that when patients receive modafinil, they will perform better on a cognitive test,
and that these benefits will depend on the dose given.
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
predict that when patients receive modafinil, they will perform better on a cognitive test,
and that these benefits will depend on the dose given.
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 the
remediation of deficits in cognition 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.
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 the
remediation of deficits in cognition 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.
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
We found this trial at
2
sites
University of California at Los Angeles The University of California, Los Angeles (UCLA) is an...
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