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PDC-1421 for Depression in Cancer Patients

Phase 1 & 2
Waitlist Available
Led By scott A Irwin, MD/PhD
Research Sponsored by BioLite, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No history of epilepsy
No other concurrent antidepressant medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 weeks
Awards & highlights

Study Summary

This trial is testing a new drug, PDC-1421, to see if it is safe and effective in cancer patients who are also experiencing depression.

Who is the study for?
This trial is for cancer patients aged 21-85 with moderate to severe depression who've had or are having cancer treatment. They must be able to swallow pills, not have a history of serious drug allergies, head trauma, epilepsy, substance abuse in the last 6 months, or use other antidepressants recently.Check my eligibility
What is being tested?
The study tests PDC-1421 capsules' safety and effective doses for treating depression in cancer patients. It's looking at how well different doses work and monitoring any side effects that occur during the trial.See study design
What are the potential side effects?
While specific side effects aren't listed here, common ones may include nausea, headaches, dizziness or sleep issues. The trial will closely monitor participants for any adverse reactions to PDC-1421.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have never had epilepsy.
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I am not taking any antidepressant medications.
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My cancer was confirmed through a tissue examination.
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My cancer is at Stage I, II, or III.
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I am between 21 and 85 years old.
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I have felt depressed for more than 2 weeks.
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I have felt depressed for more than 2 weeks.
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I can swallow pills.
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I have never had a head injury.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 weeks 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-Åsberg Depression Rating Scale (MADRS)

Side effects data

From 2019 Phase 2 trial • 72 Patients • NCT02395978
17%
Glaucoma
17%
Viral upper respirator tract infection
17%
Acne
100%
80%
60%
40%
20%
0%
Study treatment Arm
Part I: 1 PDC-1421 Capsule
Part I: 2 PDC-1421 Capsule
Part II: 2 PDC-1421 Capsule
Part II: 1 PDC-1421 Capsule Plus 1 Placebo
Part II: 2 Placebo

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2 PDC-1421 CapsulesExperimental Treatment1 Intervention
2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
Group II: 1 PDC-1421 CapsuleExperimental Treatment1 Intervention
1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDC-1421 Capsule
2015
Completed Phase 2
~80

Find a Location

Who is running the clinical trial?

BioLite, Inc.Lead Sponsor
6 Previous Clinical Trials
303 Total Patients Enrolled
2 Trials studying Depression
102 Patients Enrolled for Depression
American BriVision CorporationUNKNOWN
2 Previous Clinical Trials
72 Total Patients Enrolled
scott A Irwin, MD/PhDPrincipal InvestigatorCedars-Sinai Health System

Media Library

PDC-1421 Capsule (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03833206 — Phase 1 & 2
Depression Research Study Groups: 1 PDC-1421 Capsule, 2 PDC-1421 Capsules
Depression Clinical Trial 2023: PDC-1421 Capsule Highlights & Side Effects. Trial Name: NCT03833206 — Phase 1 & 2
PDC-1421 Capsule (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03833206 — Phase 1 & 2
~8 spots leftby Feb 2025
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