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

Phase 2
Waitlist Available
Research Sponsored by Perception Neuroscience
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours, 4 hours, 24 hours, 7 days and 14 days

Summary

This trial tests a new treatment for adults with depression that hasn't improved with other treatments. Participants will receive either the new treatment or another option without knowing which one. The goal is to see if the new treatment can help reduce their depression symptoms.

Eligible Conditions
  • Major Depressive Disorder

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours, 4 hours, 24 hours, 7 days and 14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours, 4 hours, 24 hours, 7 days and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours
Secondary study objectives
Clinical Global Impression - Improvement (CGI-I)
Clinical Global Impression - Severity (CGI-S) Change From Baseline
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change From Baseline
+6 more

Side effects data

From 2022 Phase 2 trial • 102 Patients • NCT05414422
12%
Somnolence
12%
Derealisation
9%
Headache
6%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
PCN-101 30 mg
PCN-101 60 mg
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: PCN-101 60 mgExperimental Treatment1 Intervention
PCN-101 60 mg
Group II: PCN-101 30 mgExperimental Treatment1 Intervention
PCN-101 30 mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PCN-101
2022
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

IQVIA BiotechIndustry Sponsor
20 Previous Clinical Trials
5,633 Total Patients Enrolled
Precision For MedicineIndustry Sponsor
4 Previous Clinical Trials
375 Total Patients Enrolled
Perception NeuroscienceLead Sponsor
1 Previous Clinical Trials
3 Total Patients Enrolled
Chief Medical OfficerStudy DirectorPerception Neuroscience
127 Previous Clinical Trials
21,891 Total Patients Enrolled
~27 spots leftby Dec 2025
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