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

NCT03833206 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: ABV-1601-001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety and the effective doses of PDC-1421 in cancer patients with depression.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• Montgomery-Åsberg Depression Rating Scale (MADRS)

  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

  5 weeks

Study Arms (2)

1 PDC-1421 Capsule

EXPERIMENTAL

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

Drug: PDC-1421 Capsule

2 PDC-1421 Capsules

EXPERIMENTAL

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

Drug: PDC-1421 Capsule

Interventions

PDC-1421 Capsule DRUG

PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.

1 PDC-1421 Capsule; 2 PDC-1421 Capsules

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• A positive response to question 4 or 5, indicating endorsement of suicidal ideation with at least some intent to act in the past month; and/or
• A positive response to part two of question 6, indicating the presence of any suicidal behavior in the past 3 months.
• 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.

Sponsors & Collaborators

• BioLite, Inc.: lead
• American BriVision Corporation: collaborator

Study Sites (1)

Cedars-Sinai Health System

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• scott A Irwin, MD/PhD

  Cedars-Sinai Health System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirley Chiu, Ph.D.

CONTACT

+886-3-657-9631; shirleychiu@bio1st.com

Hsien-Ming Wu, MS

CONTACT

+886-3-657-9631; sonnywu@bioliteinc.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 6, 2019
• Study Start (Estimated): January 15, 2027
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): February 28, 2028
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

US (1)