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PDC-1421 for Depression in Cancer Patients

This study is testing PDC-1421 Capsule, a botanical investigational drug made from Radix Polygalae, to see if it is safe and what doses are effective for treating depression in cancer patients. You may be able to join if you are 21 to 85 years old, have Stage I, II, or III cancer, and are currently receiving or have recently received cancer treatment. You also need to have moderate to severe depressive symptoms (a score of 20 or higher on the Montgomery-Åsberg Depression Rating Scale, or MADRS) for at least two weeks. The study will measure changes in your depression symptoms using the MADRS after 5 weeks. This study plans to enroll 12 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 12 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your depression symptoms will be measured at 5 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03833206

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

Not Yet Recruiting
PHASE1Ages 21–85InterventionalTreatment
BioLite, Inc.
~12 participants
Updated 2026-04-20 on ClinicalTrials.gov
What's tested:PDC-1421 Capsule

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Montgomery-Åsberg Depression Rating Scale (MADRS)
Measured over 5 weeks

Conditions

Major Depressive Disorder

Explore related trials

Malignant NeoplasmUnipolar Depression

Where it's being run

1 sites across 1 states
California1

Study leadership

  • scott A Irwin, MD/PhD · PRINCIPAL_INVESTIGATOR · Cedars-Sinai Health System

Who to contact

Shirley Chiu, Ph.D.
[email protected]
+886-3-657-9631
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Have a current or previous diagnosis of or history consistent with obsessive-compulsive disorder, posttraumatic stress disorder, bipolar I or II, manic or hypomanic episodes, schizophrenia, major Axis II disorders which might compromise the study, or major depression with psychotic symptoms, as assessed using the MINI International Neuropsychiatric Interview (MINI Plus).
Have a documented history of an intellectual disability.
Use of any antidepressant medication in the last 2 weeks before visit 1 (4 weeks for fluoxetine).
Currently being treated with tamoxifen.
Subjects who were non-responsive to two or more courses of antidepressant medications given at an adequate dosage\* for symptom treatment within four weeks, or by the judgment of the investigator considered to have treatment resistant depression (TRD), or a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) or psychosurgery within the last year.
Have a history of any seizure disorder.
Any clinically significant abnormal vital sign, ECG, or laboratory values as determined by the investigator which might interfere with the study.
Have a high suicidal risk as assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS). High suicidal risk is indicated by:
Have a history of substance dependence/abuse\*\* within the past 6 months or a positive drug screen result during the screening period.
Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
\* An adequate dosage of the antidepressant medication is defined as the average of the usual dose (mg/day) recommended in American Psychiatric Association (APA) Practice Guideline for the Treatment of Patients with Major Depressive Disorder, Third Edition. E.g. the usual dose of Citalopram is 20-60 mg/day, the adequate dosage is 40 mg/day.
\*\* Tobacco is excluded here, and alcohol abuse is defined as average pure alcohol intake is more than 112 g (for male) or 56 g (for female) per week and/or with Alcohol withdrawal syndrome. Pure alcohol intake =% (Concentration or alcohol content) x c.c. (volume)x 0.79 (density of alcohol). Result of serum ethanol test should be equal to or lower than 10.0 mg/dL to be determined as eligible for the trial. If test result is between 10.1 to 29.9 mg/dL, only one re-test is allowed per subject to meet the criterion. Subject with test result equal to or higher than 30.0 mg/dL is to be excluded.

What this trial measures

  • Montgomery-Åsberg Depression Rating Scale (MADRS)5 weeks

    Change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline to week 1, 2, 3, 4, and 5 in patients taking 1 or 2 PDC-1421 capsules. The MADRS is a 10-item checklist including 1) depression \[apparent\]; 2) depression \[reported\]; 3) loss of interest; 4) suicidal ideation; 5) tension; 6) reduced appetite; 7) insomnia; 8) difficulty in activities; 9) concentration; and 10) pessimism. The MADRS is administered by a trained interviewer. Each item is rated on a scale of 0-6, with anchors at 2-point intervals; higher scores indicating more severity (i.e., ranging from 0 \[no sadness\] to 6 \[extremely despondent\]). The total score is used to define treatment response (≥50% reduction from baseline) and partial response (20-49% reduction from baseline). Remission is defined as a score of \< 10. The following are used as an interpretation of scores: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression