CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 102 enrolled
Drug / intervention
PCN-101 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05414422
NCT05414422Phase 2Completed
CompareCT.gov

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

Perception Neuroscience·interventional·Posted Jun 10, 2022·Updated Jun 4, 2024

In Brief

A Phase 2 clinical trial evaluating PCN-101 and Placebo for Treatment Resistant Depression. Completed, enrolled 102 participants across 21 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTreatment Resistant Depression
CountriesGermany, Poland, United States
CollaboratorsPrecision For Medicine, IQVIA Biotech

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJun 10, 2022
Enrollment StartFeb 1, 2022
Primary CompletionNov 10, 2022
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 4.1 years ago

Interventions

PCN-101drug

Concentrate for solution for infusion

Placebodrug

Concentrate for solution for infusion