Schizophrenia Clinical Trial
Official title:
Effect of MMFS-202-302 on Cognitive Enhancement in Schizophrenia
The goals of this study are to study MMFS-202-302 in a double blind, randomized, placebo-controlled 9-week study of its effect on ameliorating cognitive deficits in 60 patients with schizophrenia or schizoaffective disorder with stable levels of positive symptoms. Secondary end points will include changes in positive and negative symptoms. One dose of MMFS-202-302 will be studied and compared with placebo as adjunctive treatment to atypical antipsychotic drug treatment.
One of the symptoms of schizophrenia is a problem with specific domains of cognition, even
when the positive symptoms have been treated. The primary goal of this study is to determine
the effectiveness of 9 weeks of supplementation with MMFS-202-302 as augmentation of atypical
antipsychotic medication, to improve a critical specific domain of cognitive function, i.e.,
working memory, in patients with schizophrenia or schizoaffective disorder. To support this
primary goal, global function will be assessed with the Clinical Global Impression assessment
of change.
The investigators will also examine the effect of MMFS-202-302 on other domains of cognition
(e.g. attention, executive function, declarative memory, etc.); negative symptoms of
schizophrenia; positive symptoms of schizophrenia; MRI measures of brain structure, resting
state functional connectivity, and function during evaluation of emotional/unemotional and
rewarding/aversive images and anticipation and receipt of reward and punishment, and working
memory; and EEG measurement of network interactivity during learning and memory recollection.
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