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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
Diagnosis of recurrent major depressive disorder (MDD) without psychotic features per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V), confirmed by Mini-International Neuropsychiatric Interview
Capable of giving and give signed informed consent
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up2 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

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have recurrent major depressive disorder (MDD) without psychotic features.
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You are taking an oral antidepressant for at least 30 days without a dose change.
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You have had a depressive episode in the past 12 months.

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

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 more

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
18 Previous Clinical Trials
4,759 Total Patients Enrolled
Perception NeuroscienceLead Sponsor
Precision For MedicineIndustry Sponsor
4 Previous Clinical Trials
375 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:
  1. Midwest Clinical Research Center: < 48 hours
Typically responds via
Phone Call
~37 spots leftby Nov 2024