This study will test whether CVL-562 (PF-06412562), a dopamine 1 partial agonist novel
compound, affects working memory neural circuits in patients with early episode
schizophrenia. The overall aim is to establish neuroimaging biomarkers of the Dopamine
Receptor 1/Dopamine Receptor 5 Family (D1R/D5R) target engagement to accelerate development
of D1R/D5R agonists in humans to treat cognitive impairments that underlie functional
disability in schizophrenia, a key unaddressed clinical and public health concern.
This study proposes to examine the effects of CVL-562 (PF-06412562), a dopamine-1 receptor
partial agonist, on the neural signal of brain regions involved in cognition in patients with
schizophrenia and related psychotic disorders. The primary objective of this study is to
understand the neural circuit targets of this compound as it relates to improving cognition
in schizophrenia, using a spatial working memory task (sWM). The secondary objective will
quantify dose-related drug effects on sWM precision based on behavioral data collected during
scanning and examine effects on functional connectivity.
All patients will be psychiatrically stable with early course (psychotic symptom onset within
the past 5 years) schizophrenia spectrum disorder (e.g. schizophrenia, schizoaffective
disorder, or schizophreniform disorder) and will have working memory deficits (defined as
below average performance on the letter n-back task of the PennCNB battery). As part of the
study, they will receive oral administration of specified doses of CVL-562 (PF-06412562), in
a random order with repeated functional magnetic resonance imaging and cognitive testing
during those visits. The most common side effects of this compound are nausea and headache.
This is a multi-site study that requires the efforts of 4 study sites in total (Columbia,
State University of New York Stony Brook, UPenn, and Yale).
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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