Predictors of placebo response in three large clinical trials of the V1a receptor antagonist balovaptan in autism spectrum disorder.

ABSTRACT: High rates of placebo response are increasingly implicated in failed autism spectrum disorder (ASD) clinical trials. Despite this, there are limited investigations of placebo response in ASD. We sought to identify baseline predictors of placebo response and quantify their influence on clinical scales of interest for three harmonized randomized clinical trials of balovaptan, a V1a receptor antagonist. We employed a two-step approach to identify predictors of placebo response on the Vineland-II two-domain composite (2DC) (primary outcome and a caregiver measure) and Clinical Global Impression (CGI) scale (secondary outcome and a clinician measure). The initial candidate predictor set of variables pertained to participant-level, site-specific, and protocol-related factors. Step 1 aimed to ide

SUBMITTER: Tobe R 

PROVIDER: S-EPMC10267133 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature