PDC-1421 for Depression in Cancer Patients

Overseen By Shirley Chiu, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: BioLite, Inc.

Must not be taking: Antidepressants, Tamoxifen

Disqualifiers: Bipolar, Schizophrenia, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new medication called PDC-1421 to see if it is safe and effective for cancer patients who also have depression. The goal is to find the right dose that helps with depression without causing harm.

Will I have to stop taking my current medications?

The trial requires that you stop taking any antidepressant medications at least 2 weeks before starting, and 4 weeks for fluoxetine. You also cannot be currently treated with tamoxifen.

Research Team

Scott Irwin, MD, PhD

Principal Investigator

Cedars-Sinai Health System

Eligibility Criteria

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.

Inclusion Criteria

Sufficient English language proficiency to complete all assessments without assistance

I have never had epilepsy.

Not pregnant

Exclusion Criteria

I have depression that didn't improve after trying at least two different treatments.

Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study

I haven't taken antidepressants in the last 2 weeks, or 4 weeks for fluoxetine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 1 or 2 PDC-1421 capsules, trice daily, p.o. after meal for 28 days

4 weeks

Weekly visits for MADRS assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

Treatment Details

Interventions

• PDC-1421 Capsule

Trial Overview 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.

Participant Groups

Group I: 2 PDC-1421 Capsules Experimental Treatment 1 Intervention

2 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days

Group II: 1 PDC-1421 Capsule Experimental Treatment 1 Intervention

1 PDC-1421 Capsule, trice daily, p.o. after meal for 28 days

Who Is Running the Clinical Trial?

BioLite, Inc.

Lead Sponsor

Trials

7

Recruited

290+

American BriVision Corporation

Collaborator

Trials

3

Recruited

80+