Schizophrenia Clinical Trial
Official title:
Randomized, Double-Blinded, Placebo Controlled Study of the Effects of Modafinil on Cognitive Function in Patients With Schizophrenia and Normal Controls Based on COMT Genotype
This study will evaluate whether modafinil improves cognition in patients with schizophrenia
and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time
sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal
cortex of the brain
...
Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of
cognitive function. For example, COMT inhibitors can slightly improve working
memory/executive function. Similarly, modafinil, a catecholaminergic agonist that increases
extracellular dopamine in the prefrontal cortex was also shown to improve delay-dependent
working memory. Differences in the response between individuals might be related to a number
of factors, including variations in the genes. The recent finding that a polymorphism in the
catechol-o-methyl-transferase (COMT) gene, which produces a 4 fold change in enzyme activity,
accounts for 4% of the variance in performance of working memory tasks in humans suggest that
COMT genotype may predict response to COMT inhibitors or to other agonists that increase
catecholaminergic function in the frontal cortex.
In the present investigation our goal is to examine, in normal controls and patients with
schizophrenia, the effect of modafinil, a drug that increases DA output in the frontal
cortex, on cognitive function and brain physiology. We predict that both normal controls and
patients with schizophrenia with the val/val genotype will have a significant improvement in
working memory compared with individuals possessing other genotypes. Furthermore, in
conjunction with other NIMH imaging protocols, we predict that modafinil will produce a
similar genotype-dependent effect on the neurophysiological correlates related to working
memory assayed with fMRI. The present protocol will provide new insights on the importance of
this genetic polymorphism in the regulation of aminergic-controlled cognitive function in
normal individuals. Furthermore, this protocol will test whether modafinil offers a new
treatment -based on genotype - for cognitive impairment in schizophrenia. The FDA granted a
waiver for the use of Modafinil in this study.
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