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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 weeks

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%

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

0 / 9Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there room for more test subjects in this experiment?

"No, this specific trial is not looking for new patients at the moment. According to clinicaltrials.gov, the last update to this posting was on October 1st, 2022. There are 867 other trials that might be a better fit for you."

Answered by AI

How can I sign up for this clinical trial?

"This trial is looking for 12 patients that suffer from involutional psychosis and are between 21-85 years old. In order to be eligible, participants must also meet the following requirements: Histologically-proven malignancy, Receiving or within one year of having received cancer treatment with radiation and/or chemotherapy, Duration of depressive symptoms ≥ 2 weeks by patient report., No active/acute suicidality requiring immediate care or psychiatric hospitalization, Able to swallow pills, Montgomery and Åsberg Depression Rating Scale (MADRS) ≥ 20 (moderate to severe depressive symptoms)."

Answered by AI

Is this research project only testing subjects that are under 40 years old?

"The ideal participants for this clinical trial are between 21 and 85 years old. There are 113 other studies available for patients under 18, and 617 for those over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients

2024. "A Phase I/II Study of PDC-1421 for Treating Depression in Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03833206.