PCN-101 for Unipolar Depression

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Kadima Neuropsychiatry Institute, La Jolla, CA
Unipolar Depression+2 More
PCN-101 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

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. The drug PCN-101 is used to treat unipolar depression and has been previously approved by the FDA for another condition.

Eligible Conditions

  • Unipolar Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 2 hours, 4 hours, 24 hours, 7 days and 14 days

14 days
Treatment-emergent adverse events summarized by treatment group, system organ class and preferred term
Day 14
Montgomery Asberg Depression Rating Scale (MADRS) >= 50% Improvement
24 hours
Montgomery Asberg Depression Rating Scale (MADRS) 24 Hours
Day 14
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
Generalized Anxiety Disorder (GAD-7) Change from Baseline
Montgomery Asberg Depression Rating Scale (MADRS) <= 10
Quick Inventory of Depressive Symptomatology (QIDS-SR-16) Change from Baseline
Day 14
Hamilton Depression Rating Scale (HAM-D) Change from Baseline

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

PCN-101 30 mg
1 of 3
PCN-101 60 mg
1 of 3
Placebo
1 of 3
Experimental Treatment
Non-Treatment Group

93 Total Participants · 3 Treatment Groups

Primary Treatment: PCN-101 · Has Placebo Group · Phase 2

PCN-101 30 mg
Drug
Experimental Group · 1 Intervention: PCN-101 · Intervention Types: Drug
PCN-101 60 mg
Drug
Experimental Group · 1 Intervention: PCN-101 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 hours, 4 hours, 24 hours, 7 days and 14 days
Closest Location: Kadima Neuropsychiatry Institute · La Jolla, CA
Photo of La Jolla 1Photo of La Jolla 2Photo of La Jolla 3
2019First Recorded Clinical Trial
0 TrialsResearching Unipolar Depression
5 CompletedClinical Trials

Who is running the clinical trial?

Perception NeuroscienceLead Sponsor
Precision For MedicineIndustry Sponsor
4 Previous Clinical Trials
374 Total Patients Enrolled
IQVIA BiotechIndustry Sponsor
18 Previous Clinical Trials
6,536 Total Patients Enrolled
Chief Medical OfficerStudy DirectorPerception Neuroscience
110 Previous Clinical Trials
19,766 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have recurrent major depressive disorder (MDD) without psychotic features.
You are taking an oral antidepressant for at least 30 days without a dose change.
You have had a depressive episode in the past 12 months.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.