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PCN-101 for Major Depressive Disorder
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
Awards & highlights
Study Summary
This trial will test whether an experimental drug is effective in treating treatment-resistant depression. The study includes 3 phases and will involve 93 adults. The study is double-blind, meaning neither the participants nor the researchers will know who is receiving the experimental drug or the placebo.
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours
Secondary outcome measures
Clinical Global Impression - Improvement (CGI-I) Change from Predose
Clinical Global Impression - Severity (CGI-S) Change from Baseline
European Quality - 5 Dimensions - 3 Levels (EQ-5D-3L) Change from Baseline
+6 moreTrial 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
18 Previous Clinical Trials
4,806 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
North Carolina
Virginia
California
Other
How old are they?
65+
18 - 65
What site did they apply to?
Preferred Research Partners
Premier Clinical Research Institute Inc.
Kadima Neuropsychiatry Institute
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Average response time
- < 2 Days
Most responsive sites:
- Midwest Clinical Research Center: < 48 hours
Typically responds via
Phone Call
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