Ulotaront, a Trace Amine-Associated Receptor 1/Serotonin 5-HT_1A Agonist, in Patients With Parkinson Disease Psychosis: A Pilot Study.

ABSTRACT:

Background and objectives

Ulotaront (SEP-363856) is a trace amine-associated receptor 1 agonist with 5-HT_1A receptor agonist activity currently in phase 3 clinical development for the treatment of schizophrenia. In this exploratory, flexibly dosed study, ulotaront was evaluated for the treatment of Parkinson disease psychosis (PDP).

Methods

Patients with PDP requiring antipsychotic therapy were randomized, double-blind to ulotaront (25, 50, or 75 mg/d) or placebo. Mixed Model for Repeated Measures was used to assess change from baseline in the Scale for the Assessment of Positive Symptoms for Parkinson Disease (SAPS-PD) at 6 weeks (primary end point).

Results

The efficacy analysis sample comprised 38 patients (ulotaront, n = 24; placebo, n = 14). SAPS-PD to

SUBMITTER: Isaacson SH 

PROVIDER: S-EPMC10238151 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature