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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 hours, 4 hours, 24 hours, 7 days and 14 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours, 4 hours, 24 hours, 7 days and 14 days
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 moreSide effects data
From 2022 Phase 2 trial • 102 Patients • NCT0541442212%
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