A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD
Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
Participant gender:
Summary
This is a double-blind, randomized, placebo-controlled, multicenter study comprised of 3
phases:screening (up to 2 weeks [Day -15 to Day -2]), In-Clinic Treatment (Day -1 to Day 2;
including double-blind treatment [Day 1]), and post-treatment follow-up (7 and 14 days after
infusion on Days 8 and 15, respectively). A total of 93 adult subjects with TRD will be
randomly allocated in equal cohorts of 31 subjects/arm to the 3 arms of the study in a
blinded manner.