The Impact Of Cannabidiol In Patients With Early Psychosis: A Randomized Controlled Trial
We aimed to study the effects of cannabidiol (CBD) in out-patients with early psychosis on clinical metrics of psychosis and cognition and on psychophysiological electroencephalogram (EEG) metrics of psychosis. Adult outpatient subjects with a primary psychotic disorder within approximately five years of psychosis onset were enrolled in a four-week, two-period, randomized, placebo-controlled crossover trial (clinicaltrials.gov NCT02504151). Subjects were randomized in a one-to-one ratio to receive either CBD (oral 800 mg/day) or placebo in the first of two treatment periods in a randomized, double-blind manner. Primary outcome measures assessed were psychosis symptoms measured using the Positive and Negative Syndrome Scale (PANSS); and cognition measured using the MATRICS Consensus Cognitive Battery (MCCB). Secondary clinical outcomes included Clinical Global Impression of Severity or of Improvement (CGI-S, CGI-I) and Quality of Life Scale (QLS). Statistical analyses were conducted using linear mixed models and nonparametric tests.