" Novel trace amine associated receptor-1 agonist SEP-363856 has significant antipsychotic effects in patients with schizophrenia, according to results of a study presented at Psych Congress 2019, held October 3 to 6 in San Diego, California. There were no notable differences between treatment with SEP-363856 and placebo in terms of safety and tolerability.
The 4-week randomized placebo-controlled phase 2 trial (ClinicalTrials.gov Identifier: NCT02969382) included patients randomly assigned to receive either once-daily SEP-363856 in doses of 50 mg or 75 mg (n=120) or placebo (n=125). Individuals included in the study were aged 18 to 40 years and met the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for schizophrenia since first diagnosis ≥6 months, had ≥2 prior hospitalizations, and experienced an acute exacerbation of psychotic symptoms. Primary and secondary efficacy end points were week 4 change in Positive and Negative Symptom Scale score, and Clinical Global Impressions-Severity and Brief Negative Symptom Scale scores, respectively."