NCT05414422

A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of PCN-101 in TRD

A Randomized, Placebo-Controlled, Double-Blind Study to Assess Safety and Efficacy of Intravenous PCN-101 in Treatment Resistant Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Perception Neuroscience · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	PCN-101	Concentrate for solution for infusion
DRUG	Placebo	Concentrate for solution for infusion

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-11-10
• Completion: 2022-11-10
• First posted: 2022-06-10
• Last updated: 2024-06-04
• Results posted: 2024-06-04

Locations

21 sites across 3 countries: United States, Germany, Poland

Regulatory

• FDA-regulated drug study